[CTMS - CTRP Documentation] Pages FeedConfluence Syndication Feedhttps://wiki.nci.nih.govCopy of Recent changes to CTRP <TSR RELEASE> - ALT 2/13/2024 v2.0Tate, Ariana (NIH/NCI) [C]tag:wiki.nci.nih.gov,2009:page-568459477-52024-03-26T21:37:55Z2024-02-13T19:22:57Z<div class="feed"> <p>
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<a href=" https://wiki.nci.nih.gov/display/~tateal
">Tate, Ariana (NIH/NCI) [C]</a>
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<p>This page provides an overview of the changes in CTRP. For any questions or issues regarding these feature enhancements, please contact the CTRO (<a href="mailto:NCICTRO@mail.nih.gov" class="external-link" rel="nofollow">NCICTRO@mail.nih.gov</a>).</p><h3 id="CopyofRecentchangestoCTRP<TSRRELEASE>ALT2/13/2024v2.0-March2024"><strong>March 2024</strong></h3><p>New CTRP <a href="http://trials.nci.nih.gov" class="external-link" rel="nofollow">trials.nci.nih.gov</a> login page and new Accrual application <span>are</span><span> </span>now live.</p><p><strong><u>New Login page</u></strong> with accompanying landing page allows users to select and launch the new Accrual, Registration, Protocol Abstraction, or Person/Organization CTRP applications.</p><p>CTRP has developed a new Accrual Reporting application available via <a href="http://trials.nci.nih.gov" class="external-link" rel="nofollow">trials.nci.nih.gov</a>. The new version maintains most of the previous Accrual <em>(</em><em>e.g., now referred to as Classic Accrual)'s</em> functionality; however, the user interface is updated, and user experience is enhanced. These enhancements include:</p><ul><li><u>Trial Search</u><ul><li>The Accrual Counts and Trial Search page in classic Accrual have been combined. Please note the Accrual Counts page is decommissioned.</li><li>The ability to show/hide columns is expanded to the newly added fields absorbed from the Accrual Counts page.</li><li>Search and filter capabilities have been expanded beyond NCI Trial Identifier, <a href="http://ClinicalTrials.gov" class="external-link" rel="nofollow">ClinicalTrials.gov</a> Identifier, and Official Title fields.</li><li>The ability to filter prior submissions by the NCI Trial Identifier is available under the “Actions” column.</li></ul></li><li><u>Study Subject</u><ul><li>Study subject records still inherit the trial record’s selected accrual disease terminology; however, study subject records are now allowed to not match the accrual disease terminology selected at trial-level.</li><li>The field “Study Subject Gender” is relabeled to display “Study Subject Sex” throughout the application.</li><li>The “Method of Payment” and “Registering Group Identifier” fields have been decommissioned throughout the new Accrual application.</li><li>Study Subject ZIP Code will allow users to enter 9 digits for US-based subjects; however, new Accrual will only save the first 5 digits.</li></ul></li><li><u>Prior Submissions</u><ul><li>The “Rejection Reason” column has been added to the page and is included in file export <em>up</em> to a <span style="color: rgb(0,0,0);">1,000 characters</span>.</li></ul></li></ul><div class="confluence-information-macro confluence-information-macro-tip"><p class="title conf-macro-render">Please Note</p><span class="aui-icon aui-icon-small aui-iconfont-approve confluence-information-macro-icon"></span><div class="confluence-information-macro-body"><p>The generated email notification for accrual submission is still providing the most comprehensive information, especially for large batch submissions. The list displayed in the new Accrual application can provide initial, aggregated information to users.</p></div></div><ul><li><u>Session Time-out Changes</u><ul><li>The new application no longer has an automatic log-out after sixty-minutes.</li></ul></li></ul><p>Learn how to use the new Accrual via updated <a href="https://wiki.nci.nih.gov/display/CTRPdoc/NCI+CTRP+Accrual+User+Guide" rel="nofollow">CTRP Accrual User Guide</a></p><ul><li style="list-style-type: none;"><ul><li>Logging in to CTRP page</li><li><a href="https://wiki.nci.nih.gov/display/CTRPdoc/NCI+CTRP+Accrual+User+Guide" rel="nofollow">Accrual User Guide</a> (updated with new Accrual information)</li></ul></li></ul><p>Please note: The new Accrual application will be <span>released in parallel with the current Classic Accrual application. Users will have the option to utilize either application for a brief period, until the Classic Accrual application is deprecated and no longer available. The use of the new Accrual application is highly encouraged.</span></p><p><strong>To access Classic Accrual: </strong><span>O</span>n main landing page, <span>within the top right-hand menu, </span><span>a user can click the Profile down button, and the Classic Accrual application is listed </span><span>within</span><span> the Quick Links menu.</span></p><p><span><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" height="400" src="https://wiki.nci.nih.gov/download/attachments/568459477/image-2024-2-16_14-48-50.png?version=1&modificationDate=1708112930000&api=v2" data-image-src="https://wiki.nci.nih.gov/download/attachments/568459477/image-2024-2-16_14-48-50.png?version=1&modificationDate=1708112930000&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="568460286" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="image-2024-2-16_14-48-50.png" data-base-url="https://wiki.nci.nih.gov" data-linked-resource-content-type="image/png" data-linked-resource-container-id="568459477" data-linked-resource-container-version="5" alt=""></span></span></p><p>Please report any technical questions about CTRP applications using <a href="mailto:ctrp_support@nih.gov" class="external-link" rel="nofollow">ctrp_support@nih.gov</a>.</p><h3 id="CopyofRecentchangestoCTRP<TSRRELEASE>ALT2/13/2024v2.0-March2023"><strong>March 2023</strong></h3><p>Update to the CTRP-generated DT4 report display to include the pragmatic trial indicator. The field is labeled ‘Prag’ with values of ‘Y’ or ‘N’ and is abstracted by the CTRO. This value will be included in any format of the CTRP-generated DT4 report (e.g., pdf, csv). This update does not have any impact on CTRP REST Services or CTRP REST Service users.</p><p><br/></p><p><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" height="250" src="https://wiki.nci.nih.gov/download/attachments/568459477/Screenshot%202023-03-07%20at%203.36.27%20PM.png?version=1&modificationDate=1707852177000&api=v2" data-image-src="https://wiki.nci.nih.gov/download/attachments/568459477/Screenshot%202023-03-07%20at%203.36.27%20PM.png?version=1&modificationDate=1707852177000&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="568459460" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="Screenshot 2023-03-07 at 3.36.27 PM.png" data-base-url="https://wiki.nci.nih.gov" data-linked-resource-content-type="image/png" data-linked-resource-container-id="568459477" data-linked-resource-container-version="5" alt=""></span></p><p>Prag values:<strong><br/></strong> Y – Yes, this is a pragmatic trial</p><p> N – No, this is not a pragmatic trial</p><p><br/></p><p>Also included in this release is the modification for the ‘Pilot’ field values to single characters on the CTRP-generated DT4 report:<br/> Yes → Y</p><p> No → N</p><p><em> (Blank) →</em>N</p><p><br/></p><p>For additional information about the pragmatic trial indicator on the CTRP-generated DT4 report, please visit the following CTRP User Guide page:</p><p><span style="color: rgb(0,0,0);text-decoration: none;"> </span><a style="text-decoration: underline;" href="https://wiki.nci.nih.gov/display/CTRPdoc/Data+Elements+Included+in+the+CTRP+Data+Table+4+Report" rel="nofollow">Data Elements Included in the CTRP Data Table 4 Report</a></p><p><br/></p><hr/><p><br/></p><p>Update to the CTRP Trial Summary Report (TSR) to include the pragmatic trial indicator. The field is labeled “Pragmatic Trial” and is in the ‘Trial Design’ table.</p><p><br/></p><p><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" height="250" src="https://wiki.nci.nih.gov/download/attachments/568459477/Screenshot%202023-03-16%20at%204.23.39%20PM.png?version=1&modificationDate=1707852177000&api=v2" data-image-src="https://wiki.nci.nih.gov/download/attachments/568459477/Screenshot%202023-03-16%20at%204.23.39%20PM.png?version=1&modificationDate=1707852177000&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="568459459" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="Screenshot 2023-03-16 at 4.23.39 PM.png" data-base-url="https://wiki.nci.nih.gov" data-linked-resource-content-type="image/png" data-linked-resource-container-id="568459477" data-linked-resource-container-version="5" alt=""></span></p><p>“Pragmatic Trial” values on the TSR:<br/> Yes – This is a pragmatic trial<br/> No – This is not a pragmatic trial<br/> No Data Available – CTRP currently does not have information as to whether or not this is a pragmatic trial </p><p>For additional information about the pragmatic trial indicator on the TSR, please visit the following CTRP User Guide page:</p><p> <a href="https://wiki.nci.nih.gov/display/CTRPdoc/Trial+Design" rel="nofollow">Trial Design</a><br/> <a href="https://wiki.nci.nih.gov/display/CTRPdoc/Pragmatic+Trial+Definition+and+Characteristics" rel="nofollow">Pragmatic Trials Definition and Characteristics </a></p><p><br/></p><h3 id="CopyofRecentchangestoCTRP<TSRRELEASE>ALT2/13/2024v2.0-August2021"><strong>August 2021</strong></h3><p>Update to the NIH Grant Information section in the CTRP Registration application. The field 'Is this trial funded by an NCI Grant?' with values of Yes/No has been updated to 'Is this trial NCI funded?' with values of Direct/Indirect/No. This field is available through the web application when registering and amending trials through the CTRP Registration user interface. This update does not have any impact on CTRP REST Services or CTRP REST Service users.</p><p style="margin-left: 30.0px;"><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" height="250" src="https://wiki.nci.nih.gov/download/attachments/568459477/image2021-8-30_12-4-0.png?version=1&modificationDate=1707852177000&api=v2" data-image-src="https://wiki.nci.nih.gov/download/attachments/568459477/image2021-8-30_12-4-0.png?version=1&modificationDate=1707852177000&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="568459461" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="image2021-8-30_12-4-0.png" data-base-url="https://wiki.nci.nih.gov" data-linked-resource-content-type="image/png" data-linked-resource-container-id="568459477" data-linked-resource-container-version="5" alt=""></span></p><p style="margin-left: 30.0px;"><u>Definitions:</u></p><p style="text-align: left;margin-left: 30.0px;"><strong>Direct</strong> - <span style="color: rgb(0,0,0);text-decoration: none;">Trials conducted under any type of contract, grant, or cooperative agreement supported by the NCI (e.g., R01, N01, SPORE, P01, U01, U10) including all National trials (e.g., NCTN, ETCTN, NCORP) and all Intramural trials conducted by the NCI Center for Cancer Research (CCR)</span><span style="color: rgb(0,0,0);text-decoration: none;">.</span></p><p style="text-align: left;margin-left: 30.0px;"><strong>Indirect</strong> - <span style="color: rgb(0,0,0);text-decoration: none;">All trials conducted at an NCI-Designated Cancer Center (with P30 center core grant), including all industrial trials – without direct NCI funding.</span></p><p style="text-align: left;margin-left: 30.0px;"><strong>No</strong> - <span style="color: rgb(0,0,0);text-decoration: none;">NCI has not provided any Direct or Indirect funding for the trial.</span></p><p style="text-align: left;margin-left: 30.0px;"><br/></p><p style="text-align: left;"><span style="color: rgb(0,0,0);text-decoration: none;">For additional information about recording NIH Grant Information in the CTRP Registration application, please visit the following CTRP User Guide page:</span></p><p style="text-align: left;margin-left: 30.0px;"><span style="color: rgb(0,0,0);text-decoration: none;"><a href="https://wiki.nci.nih.gov/display/CTRPdoc/Recording+NIH+Grants">Recording NIH Grants</a></span></p><h3 id="CopyofRecentchangestoCTRP<TSRRELEASE>ALT2/13/2024v2.0-July2021"><strong>July 2021</strong></h3><p>IRB fields are now exposed in the CTRP Registration application. IRB information can be added/modified when registering, updating/verifying and amending non-industrial trials. IRB fields are read-only when viewing trials on the Trial Details Page.</p><p style="margin-left: 30.0px;"><u>Registering, Amending or Updating/Verifying a non-industrial trial: IRB fields are modifiable</u></p><p style="margin-left: 30.0px;"><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" height="250" src="https://wiki.nci.nih.gov/download/attachments/568459477/image2021-7-22_17-3-4.png?version=1&modificationDate=1707852177000&api=v2" data-image-src="https://wiki.nci.nih.gov/download/attachments/568459477/image2021-7-22_17-3-4.png?version=1&modificationDate=1707852177000&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="568459470" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="image2021-7-22_17-3-4.png" data-base-url="https://wiki.nci.nih.gov" data-linked-resource-content-type="image/png" data-linked-resource-container-id="568459477" data-linked-resource-container-version="5" alt=""></span></p><p style="margin-left: 30.0px;"><br/></p><p style="margin-left: 30.0px;"><u>Viewing a trial on the Trial Search page: IRB fields are read-only</u></p><p style="margin-left: 30.0px;"><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" height="250" src="https://wiki.nci.nih.gov/download/attachments/568459477/image2021-7-22_17-3-53.png?version=1&modificationDate=1707852177000&api=v2" data-image-src="https://wiki.nci.nih.gov/download/attachments/568459477/image2021-7-22_17-3-53.png?version=1&modificationDate=1707852177000&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="568459469" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="image2021-7-22_17-3-53.png" data-base-url="https://wiki.nci.nih.gov" data-linked-resource-content-type="image/png" data-linked-resource-container-id="568459477" data-linked-resource-container-version="5" alt=""></span></p><p style="margin-left: 30.0px;"><br/></p><p>For additional information about the IRB fields in the CTRP Registration application, please visit these CTRP User Guide pages:</p><p style="margin-left: 30.0px;"><a href="https://wiki.nci.nih.gov/display/CTRPdoc/Recording+Institutional+Review+Board+%28IRB%29+Information+-+Include+v4.5" rel="nofollow">Recording Institutional Review Board (IRB) Information</a></p><p style="margin-left: 30.0px;"><a href="https://wiki.nci.nih.gov/display/CTRPdoc/Updating+Institutional+Review+Board+%28IRB%29+Information+in+Complete+Trials+-+Include+v4.5" rel="nofollow">Updating Institutional Review Board (IRB) Information in Complete Trials</a></p><p style="margin-left: 30.0px;"><br/></p><h3 id="CopyofRecentchangestoCTRP<TSRRELEASE>ALT2/13/2024v2.0-June2021"><strong>June 2021</strong></h3><p><u>Transition to the NCIs multi-factor authentication system, Okta:</u> <strong>Your CTRP username is now your institutional email address</strong>.</p><p>Migration of CTRP user accounts to Okta. Okta multi-factor authentication is used to provide additional security beyond just entering a username and password. Each Okta account requires the configuration of at least one of the following methods:</p><ul><li>Okta Verify: Use a 'Push Notification' sent to the Okta app on the users mobile device.</li><li>SMS Authentication: Enter a single-use code sent to the users mobile device.</li><li>Voice Call Authentication - Phone call authentication by following voice instructions.</li></ul><h4 id="CopyofRecentchangestoCTRP<TSRRELEASE>ALT2/13/2024v2.0-NewCTRPloginpage">New CTRP login page</h4><h3 style="margin-left: 30.0px;" id="CopyofRecentchangestoCTRP<TSRRELEASE>ALT2/13/2024v2.0-"><strong><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" height="250" src="https://wiki.nci.nih.gov/download/attachments/568459477/image2021-6-23_17-34-36.png?version=1&modificationDate=1707852177000&api=v2" data-image-src="https://wiki.nci.nih.gov/download/attachments/568459477/image2021-6-23_17-34-36.png?version=1&modificationDate=1707852177000&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="568459462" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="image2021-6-23_17-34-36.png" data-base-url="https://wiki.nci.nih.gov" data-linked-resource-content-type="image/png" data-linked-resource-container-id="568459477" data-linked-resource-container-version="5" alt=""></span></strong></h3><p>For additional information about creating and setting up an Okta account, please visit these CTRP User Guide pages:</p><p style="margin-left: 30.0px;"><a href="https://wiki.nci.nih.gov/display/CTRPdoc/Creating+a+CTRP+Account">Creating a CTRP Account</a></p><p style="margin-left: 30.0px;"><a href="https://wiki.nci.nih.gov/display/CTRPdoc/CTRP+Okta+Account+Setup">CTRP Okta Account Setup</a></p><p><br/></p><h3 id="CopyofRecentchangestoCTRP<TSRRELEASE>ALT2/13/2024v2.0-March2021"><strong>March 2021</strong></h3><p><u><span style="color: windowtext;text-decoration: none;">U</span><span style="color: rgb(0,0,0);text-decoration: none;">pdates</span><span style="color: windowtext;text-decoration: none;"> </span><span style="color: rgb(0,0,0);text-decoration: none;">to the Data Table 4 (DT4) Anatomic Site values displayed on the CTRP-generated DT4 report:</span></u></p><div class="table-wrap"><table class="wrapped confluenceTable" style="margin-left: 30.0px;"><colgroup><col/><col/></colgroup><tbody style="margin-left: 30.0px;"><tr style="margin-left: 30.0px;"><td style="margin-left: 30.0px;" class="confluenceTd"><p style="margin-left: 30.0px;"><strong>Previous DT4 Anatomic Site Value<span> </span></strong></p></td><td style="margin-left: 30.0px;" class="confluenceTd"><p style="margin-left: 30.0px;"><strong>Updated DT4 Anatomic Site Value<span> </span></strong></p></td></tr><tr style="margin-left: 30.0px;"><td style="margin-left: 30.0px;" class="confluenceTd"><p style="margin-left: 30.0px;">Leukemia, not otherwise specified</p></td><td style="margin-left: 30.0px;" class="confluenceTd"><p style="margin-left: 30.0px;">Leukemia, other</p></td></tr><tr style="margin-left: 30.0px;"><td style="margin-left: 30.0px;" class="confluenceTd"><p style="margin-left: 30.0px;">Breast – Female</p></td><td style="margin-left: 30.0px;" class="confluenceTd"><p style="margin-left: 30.0px;">Breast</p></td></tr><tr style="margin-left: 30.0px;"><td style="margin-left: 30.0px;" class="confluenceTd"><p style="margin-left: 30.0px;">Breast – Male</p></td><td style="margin-left: 30.0px;" class="confluenceTd"><p style="margin-left: 30.0px;">Breast</p></td></tr><tr style="margin-left: 30.0px;"><td style="margin-left: 30.0px;" class="confluenceTd"><p style="margin-left: 30.0px;">Hodgkin's Lymphoma</p></td><td style="margin-left: 30.0px;" class="confluenceTd"><p style="margin-left: 30.0px;">Hodgkin Lymphoma</p></td></tr><tr style="margin-left: 30.0px;"><td style="margin-left: 30.0px;" class="confluenceTd"><p style="margin-left: 30.0px;">Non-Hodgkin's Lymphoma</p></td><td style="margin-left: 30.0px;" class="confluenceTd"><p style="margin-left: 30.0px;">Non-Hodgkin Lymphoma</p></td></tr><tr style="margin-left: 30.0px;"><td style="margin-left: 30.0px;" class="confluenceTd"><p style="margin-left: 30.0px;">Soft Tissue / Sarcoma</p></td><td style="margin-left: 30.0px;" class="confluenceTd"><p style="margin-left: 30.0px;">Soft Tissue</p></td></tr></tbody></table></div><p style="margin-left: 30.0px;">Note: For trials with numerous “Primary Sites” (DT4 Anatomic Sites), the value “Multiple” for the DT4 Anatomic Site Code will be used and displayed on the CTRP-generated DT4 report. <em>All existing trials in CTRP have been updated to reflect this change as well.</em></p><p style="margin-left: 30.0px;"><br/></p><p><span style="letter-spacing: 0.0px;">For a complete list of DT4 anatomic site values displayed on the CTRP-generated DT4 report, please visit this CTRP </span>User<span style="letter-spacing: 0.0px;"> Guide page:</span></p><p style="margin-left: 30.0px;"><a href="https://wiki.nci.nih.gov/display/CTRPdoc/Data+Table+4+Anatomic+Site+Values">Data Table 4 Anatomic Site Values</a></p><p><br/></p><p><u>Removal of the following fields from the Trial Summary Report (TSR):</u></p><ul style="list-style-type: square;"><li>Keywords</li><li>Program Code in the Data Table 4 Section</li><li>Target Accrual in the Participating Sites Section</li><li>Reporting Data Set Method</li></ul><h3 id="CopyofRecentchangestoCTRP<TSRRELEASE>ALT2/13/2024v2.0-September2020"><strong>September 2020</strong></h3><p><u>CTRP Trial Record Verification</u>: <span style="letter-spacing: 0.0px;">Improved the user experience for CTRP trial owners, trial submitters and site administrators with Verifying, Updating and/or Amending their trial records. <span style="color: rgb(0,0,0);text-decoration: none;">Key highlights from this enhancement include:</span></span></p><ol><li>New page highlighting all <strong>Trials Needing Verification<br/><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" height="250" src="https://wiki.nci.nih.gov/download/attachments/568459477/image2020-9-14_11-41-35.png?version=1&modificationDate=1707852177000&api=v2" data-image-src="https://wiki.nci.nih.gov/download/attachments/568459477/image2020-9-14_11-41-35.png?version=1&modificationDate=1707852177000&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="568459466" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="image2020-9-14_11-41-35.png" data-base-url="https://wiki.nci.nih.gov" data-linked-resource-content-type="image/png" data-linked-resource-container-id="568459477" data-linked-resource-container-version="5" alt=""></span><br/></strong></li><li>Ability to view all trial details on the <strong>Verify</strong> screen<br/><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" height="250" src="https://wiki.nci.nih.gov/download/attachments/568459477/image2020-9-14_11-43-16.png?version=1&modificationDate=1707852177000&api=v2" data-image-src="https://wiki.nci.nih.gov/download/attachments/568459477/image2020-9-14_11-43-16.png?version=1&modificationDate=1707852177000&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="568459465" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="image2020-9-14_11-43-16.png" data-base-url="https://wiki.nci.nih.gov" data-linked-resource-content-type="image/png" data-linked-resource-container-id="568459477" data-linked-resource-container-version="5" alt=""></span></li><li>Simplified workflow allowing users to <strong>Verify, Update </strong>or <strong>Amend</strong> trials within same form</li><li>New monthly email notification for alerting trial owners, trial submitters, <br/>and site administrators of <strong>Trials Needing Verification<br/><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" height="250" src="https://wiki.nci.nih.gov/download/attachments/568459477/image2020-9-14_11-44-27.png?version=1&modificationDate=1707852177000&api=v2" data-image-src="https://wiki.nci.nih.gov/download/attachments/568459477/image2020-9-14_11-44-27.png?version=1&modificationDate=1707852177000&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="568459464" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="image2020-9-14_11-44-27.png" data-base-url="https://wiki.nci.nih.gov" data-linked-resource-content-type="image/png" data-linked-resource-container-id="568459477" data-linked-resource-container-version="5" alt=""></span><br/></strong></li></ol><p><strong><br/></strong><span style="color: rgb(0,0,0);text-decoration: none;">For additional information on the CTRP Trial Record Verification processes, please visit these CTRP User Guide pages:</span><span style="color: rgb(0,0,0);text-decoration: none;"><br/></span></p><p style="margin-left: 30.0px;"><a href="https://wiki.nci.nih.gov/display/CTRPdoc/Updating+Trial+Information" rel="nofollow">https://wiki.nci.nih.gov/display/CTRPdoc/Updating+Trial+Information</a></p><p style="margin-left: 30.0px;"><a href="https://wiki.nci.nih.gov/display/CTRPdoc/How+to+Verify+Trial+Data" rel="nofollow">https://wiki.nci.nih.gov/display/CTRPdoc/How+to+Verify+Trial+Data</a></p><p style="margin-left: 30.0px;"><a href="https://wiki.nci.nih.gov/display/CTRPdoc/How+to+Access+the+Trial+Data+Verification+Page" rel="nofollow">https://wiki.nci.nih.gov/display/CTRPdoc/How+to+Access+the+Trial+Data+Verification+Page</a></p><p style="margin-left: 30.0px;"><a href="https://wiki.nci.nih.gov/display/CTRPdoc/Amending+Trials" rel="nofollow">https://wiki.nci.nih.gov/display/CTRPdoc/Amending+Trials</a></p><h3 id="CopyofRecentchangestoCTRP<TSRRELEASE>ALT2/13/2024v2.0-July2020">July 2020</h3><p><u>Flexible Accrual</u>: Enhanced the CTRP accrual reporting capabilities to include more “Flexible Accrual” reporting options. Centers can now request to update the default accrual reporting type on a study registered in CTRP. Changing the default accrual reporting type <u>requires a ticket to be submitted to the CTRO (<a href="mailto:NCICTRO@mail.nih.gov" class="external-link" rel="nofollow">NCICTRO@mail.nih.gov</a>) for review and approval</u>, before any change is granted.</p><ol><li><p>The current default accrual reporting types are as follows:</p><div class="table-wrap"><table class="wrapped confluenceTable"><colgroup><col/><col/></colgroup><tbody><tr><td class="confluenceTd"><p><strong>Trial Type</strong></p></td><td class="confluenceTd"><p><strong>Default Accrual Reporting Type</strong></p></td></tr><tr><td class="confluenceTd"><p>Complete Interventional</p></td><td class="confluenceTd"><p>Subject </p></td></tr><tr><td class="confluenceTd"><p>Complete Non-Interventional</p></td><td class="confluenceTd"><p>Subject </p></td></tr><tr><td class="confluenceTd"><p>Abbreviated/Imported Interventional</p></td><td class="confluenceTd"><p>Summary </p></td></tr><tr><td class="confluenceTd"><p>Abbreviated/Imported Non-Interventional</p></td><td class="confluenceTd"><p>Summary </p></td></tr></tbody></table></div><p><span style="color: rgb(0,0,0);text-decoration: none;"> </span></p></li><li><span style="color: rgb(0,0,0);text-decoration: none;">CTRP is also introducing a new accrual reporting type, “Partial Subject.” Partial Subject accrual requires the reporting of Study Subject ID, Registration Date and Participating Site data only. The other accrual data fields are optional. The reporting of Partial Subject accrual also <u>requires a ticket to be submitted to the CTRO (<a href="mailto:NCICTRO@mail.nih.gov" class="external-link" rel="nofollow"><span style="color: windowtext;">NCICTRO@mail.nih.gov</span></a>) for review and approval</u>, before any change is granted.</span></li><li><span style="color: rgb(0,0,0);text-decoration: none;"><strong>Accrual Data Element changes</strong>:</span><ol><li><span style="color: rgb(0,0,0);text-decoration: none;"><u>Study Subject Birth Date</u>: For any/all ways to report accrual, only the month and year (MM/YYYY) are required to be collected.</span></li><li><span style="color: rgb(0,0,0);text-decoration: none;"><u>Study Subject Country</u>: Required for all methods of reporting accrual (was previously optional)</span></li><li><span style="color: rgb(0,0,0);text-decoration: none;"><u>Disease</u>:</span><ol><li><span style="color: rgb(0,0,0);text-decoration: none;">Study Subject: Required</span></li><li><span style="color: rgb(0,0,0);text-decoration: none;">Partial Subject: Not required. However, for ICD-O-3 Disease Codes if Disease is reported, then Site must be reported.</span></li></ol></li><li><span style="color: rgb(0,0,0);text-decoration: none;"><u>Site</u>: </span><ol><li><span style="color: rgb(0,0,0);text-decoration: none;">Study Subject: Required</span></li><li><span style="color: rgb(0,0,0);text-decoration: none;">Partial Subject: Not required. However, for ICD-O-3 Disease Codes if Site is reported, then Disease must be reported.</span></li></ol></li><li><span style="color: rgb(0,0,0);text-decoration: none;"><u>Disease Codes</u>: CTRP uses a hybrid model with the codes from IACR and the codes in NCI SEER that are not available in IACR.</span></li></ol></li></ol><p style="margin-left: 60.0px;"><br/></p><p><span style="color: rgb(0,0,0);text-decoration: none;">For additional information on the CTRP Accrual process, including Flexible Accrual, Partial Subject accrual and other changes made within the Accrual application (e.g., ability to Delete All Trial Study Subjects,) please visit these CTRP User Guide pages:</span></p><p style="margin-left: 30.0px;"><span style="color: rgb(51,102,255);text-decoration: none;"><a style="color: rgb(51,102,255);" href="https://wiki.nci.nih.gov/display/CTRPdoc/About+Accrual" rel="nofollow">https://wiki.nci.nih.gov/display/CTRPdoc/About+Accrual</a></span></p><p style="margin-left: 30.0px;"><span style="color: rgb(51,102,255);text-decoration: none;"><a style="color: rgb(51,102,255);" href="https://wiki.nci.nih.gov/display/CTRPdoc/Searching+for+Trials+in+Accrual" rel="nofollow">https://wiki.nci.nih.gov/display/CTRPdoc/Searching+for+Trials+in+Accrual</a></span></p><p><span style="color: rgb(0,0,0);text-decoration: none;">If you would like to receive future CTRP announcements you may add yourself to the list here: <a href="https://list.nih.gov/cgi-bin/wa.exe?SUBED1=ctrp-users-l&A=1" class="external-link" rel="nofollow">https://list.nih.gov/cgi-bin/wa.exe?SUBED1=ctrp-users-l&A=1</a></span></p>
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</div>Tate, Ariana (NIH/NCI) [C]2024-02-13T19:22:57ZCopy of Uploading CTRP Accrual Batch Data Files - Include v4.4 - ALT 2/15/2024 v2.0Tate, Ariana (NIH/NCI) [C]tag:wiki.nci.nih.gov,2009:page-568459925-22024-03-26T21:25:52Z2024-02-15T12:31:30Z<div class="feed"> <p>
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<p><strong style="text-decoration: none;text-align: left;">Note:</strong><span style="color: rgb(0,0,0);text-decoration: none;"> The new submission for a trial will completely REPLACE the previous submission (count history) of this trial. In order to maintain the count history, the user will need to attach the previous submissions in the same batch file.</span></p><div class="confluence-information-macro confluence-information-macro-information"><p class="title conf-macro-render">Be sure to complete your batch file preparation first</p><span class="aui-icon aui-icon-small aui-iconfont-info confluence-information-macro-icon"></span><div class="confluence-information-macro-body"><p>Before you begin, gather all the protocol data you need. See<span class="confluence-link"> <a href="https://wiki.nci.nih.gov/display/CTRP/Preparing+CTRP+Accrual+Batch+Files"> <span class="confluence-link">Preparing CTRP Accrual Batch Files</span> </a> f</span>or instructions. The system logs you out if it detects that you have not used the application for 90 minutes. </p></div></div><p><div class="confluence-information-macro confluence-information-macro-tip"><span class="aui-icon aui-icon-small aui-iconfont-approve confluence-information-macro-icon"></span><div class="confluence-information-macro-body"><p>The system locks you out after three unsuccessful attempts to log in within 24 hours. In the event that you have been locked out of your account, contact us at <a href="mailto:ctrp_support@nih.gov" class="external-link" rel="nofollow">ctrp_support@nih.gov</a>. If you have forgotten your password, or if you want to reset it for any reason, refer to <a href="https://wiki.nci.nih.gov/display/CTRPdoc/Resetting+Your+Password">Resetting Your Password</a>.</p></div></div></p><p>Once you have created your Accrual Batch Upload file, upload it via the CTRP Accrual web interface. Existing accrual data for the study will be updated and any new data you submit will be added.</p><div class="confluence-information-macro confluence-information-macro-note"><span class="aui-icon aui-icon-small aui-iconfont-warning confluence-information-macro-icon"></span><div class="confluence-information-macro-body"><p>The batch upload template currently does NOT provide a way to enter accrual disease code terminology; instead, the default value of SDC is used.</p></div></div><div class="confluence-information-macro confluence-information-macro-information"><span class="aui-icon aui-icon-small aui-iconfont-info confluence-information-macro-icon"></span><div class="confluence-information-macro-body"><p>The batch files you submit do not delete previously accrued patients/patient data. Use the Accrual application user interface to delete accrued subjects as necessary.</p></div></div><p><strong>How to Upload Accrual Batch Files</strong></p><ol><li>On the left-hand navigation menu, click <strong>Batch Upload</strong> <br/>The Batch Upload page appears. <br/><em><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image confluence-content-image-border" draggable="false" width="867" src="https://wiki.nci.nih.gov/download/attachments/568459925/image-2024-3-26_17-24-26.png?version=1&modificationDate=1711488266357&api=v2" data-image-src="https://wiki.nci.nih.gov/download/attachments/568459925/image-2024-3-26_17-24-26.png?version=1&modificationDate=1711488266357&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="581009582" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="image-2024-3-26_17-24-26.png" data-base-url="https://wiki.nci.nih.gov" data-linked-resource-content-type="image/png" data-linked-resource-container-id="568459925" data-linked-resource-container-version="2" alt=""></span><br/></em></li><li><p>Click <strong>Browse</strong> and select the .txt or .zip file that contains your accrual data.</p></li><li><p>Click <strong>Submit</strong>.<br/>Your file is uploaded to the system and processed in the backgroundWhen processing has been completed, the system sends you an email message to inform you of the status of your file(s). It includes the information listed below. The system will also notify you if it is unable to process your Zip file. </p></li></ol><ul><li>NCI Identifier</li><li>Number of subject accruals that the system imported</li><li>Details of any errors that may have occurred during the import process</li></ul><div class="confluence-information-macro confluence-information-macro-note"><span class="aui-icon aui-icon-small aui-iconfont-warning confluence-information-macro-icon"></span><div class="confluence-information-macro-body"><p>The system checks your submissions to ensure there are no duplicates. The system does not process a study subject record if it detects that a participating site in the same trial has registered a subject with the same Study Subject ID. The system includes details about which Study Subject IDs are affected in an error message.</p><p>A subject is duplicate if </p><p> 1. There is already an accrual with same subject id on the same PS for a trial.</p><p> 2. If following attributes (subject id, dob, gender, ethnicity) match for a subject on any other PS on the trial(not including the PS accrual is added to).</p></div></div><p><br/></p><p class="_mce_tagged_br">Once you have uploaded your batch file, the CTRP system continues to update the record status both by email and Accrual. To view the information you uploaded, see <span class="confluence-link"> <span class="confluence-link"> <a href="https://wiki.nci.nih.gov/display/CTRPdoc/Downloading+Accrual+Batch+Data+Files">Downloading Accrual Batch Data Files</a> </span> </span> and<span class="confluence-link"> </span> <a href="https://wiki.nci.nih.gov/display/CTRPdoc/Reviewing+and+Updating+Prior+Accrual+Submissions"> <span class="confluence-link">Reviewing and Updating Prior Accrual Submissions</span></a>.</p><p class="_mce_tagged_br"><br/></p>
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</div>Tate, Ariana (NIH/NCI) [C]2024-02-15T12:31:30ZCopy of Accrual Data Elements Table with CTRP-Accepted Values for Complete Trials - Include v4.8 - ALT 2/15/2024 v2.0Tate, Ariana (NIH/NCI) [C]tag:wiki.nci.nih.gov,2009:page-568459953-42024-03-26T20:04:45Z2024-02-15T14:14:17Z<div class="feed"> <p>
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<div class="table-wrap"><table class="wrapped confluenceTable"><tbody class=""><tr class=""><td class="confluenceTd"><p><span> </span></p></td><td class="confluenceTd"><p><span> </span></p></td><td colspan="2" rowspan="1" class="confluenceTd"><p><strong><span><span>Required (R)/Conditional (C)</span></span></strong><span> </span></p></td><td class="confluenceTd"><p><span> </span></p></td></tr><tr class=""><td class="confluenceTd"><p><strong><span><span>Accrual Data Element</span></span></strong><span> </span></p></td><td class="confluenceTd"><p><strong><span><span>Definition</span></span></strong><span> </span></p></td><td class="confluenceTd"><p><strong><span><span>Subject</span></span></strong><span> </span></p></td><td class="confluenceTd"><p><strong><span><span>Partial Subject</span></span></strong><span> </span></p></td><td class="confluenceTd"><p><strong><span><span>Accepted Values</span></span></strong><span> </span></p></td></tr><tr class=""><td class="confluenceTd"><p><strong><span><span>Study Subject ID</span></span></strong><span> </span></p></td><td class="confluenceTd"><p><span><span>Enter the unique Patient ID as per the lead </span><span>organization or the study site where the subject is registered.</span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>R</span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>R</span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>Any numeric or alphanumeric value</span></span><span> </span></p></td></tr><tr class=""><td class="confluenceTd"><p><strong><span><span>Study Subject Birthdate</span></span></strong></p></td><td class="confluenceTd"><p><span><span>Enter the subject's month and year of birth in the format </span></span><strong><span><span>MM/YYYY</span></span></strong><span><span>.</span></span><span> </span></p><p><strong><span><span>Note: The subject's age reported in CTRP </span><span>cannot be greater than 120 years.</span></span></strong><span> </span></p></td><td class="confluenceTd"><p><span><span>R</span></span><span> </span></p></td><td class="confluenceTd"><p><span> </span></p></td><td class="confluenceTd"><p><span><span>Accrual application format: MM/YYYY</span></span><span> <br/></span><span><span>REST Services format: Y</span></span><span><span>YYY-MM-DD</span></span><span> <br/></span><span><span>Batch Upload format: YYYYMM</span></span><span> </span></p></td></tr><tr class=""><td class="confluenceTd"><p><strong><span><span>Study Subject </span><span>S</span><span>ex</span></span></strong><span> </span></p></td><td class="confluenceTd"><p><span><span>Select the sub</span></span><span><span>ject’s biological sex. If biological sex inform</span></span><span><span>ation is not available, select </span></span><strong><span><span>Unknown</span></span></strong><span><span>.</span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>R</span></span><span> </span></p></td><td class="confluenceTd"><p><span> </span></p></td><td class="confluenceTd"><p><span><span>Male</span></span><span> <br/></span><span><span>Female</span></span><span> <br/></span><span><span>Unspecified</span></span><span> <br/></span><span><span>Undifferentiated</span></span><span> <br/></span><span><span>Unknown</span></span><span> </span></p></td></tr><tr class=""><td class="confluenceTd"><p><strong><span><span>Study Subject Race</span></span></strong><span> </span></p></td><td class="confluenceTd"><p><span><span>Select one or more values for race. </span></span><span> </span></p><p><span><span>To select multiple races, select one race, and then press and hold the </span></span><strong><span><span>CTRL</span></span></strong><span><span>/</span></span><strong><span><span>CMD</span></span></strong><span><span> key as you select the other(s).</span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>R</span></span><span> </span></p></td><td class="confluenceTd"><p><span> </span></p></td><td class="confluenceTd"><p><span><span>American Indian or </span><span>Alaska Native</span></span><span> <br/></span><span><span>Asian</span></span><span> <br/></span><span><span>Black or African American</span></span><span> <br/></span><span><span>Native Hawaiian or Other Pacific Islander</span></span><span> <br/></span><span><span>Not Reported</span></span><span> <br/></span><span><span>Unknown</span></span><span> <br/></span><span><span>White</span></span><span> </span></p></td></tr><tr class=""><td class="confluenceTd"><p><strong><span><span>Study Subject Ethnicity</span></span></strong><span> </span></p></td><td class="confluenceTd"><p><span><span>Select a value for ethnicity.</span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>R</span></span><span> </span></p></td><td class="confluenceTd"><p><span> </span></p></td><td class="confluenceTd"><p><span><span>Hispanic or Latino</span></span><span> <br/></span><span><span>Not Hispanic or Latino</span></span><span> <br/></span><span><span>Not Reported</span></span><span> <br/></span><span><span>Unknown</span></span><span> </span></p></td></tr><tr class=""><td class="confluenceTd"><p><strong><span><span>Study </span><span>Subject Country</span></span></strong><span> </span></p></td><td class="confluenceTd"><p><span><span>Select the study subject's country of residence.</span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>R</span></span><span> </span></p></td><td class="confluenceTd"><p><span> </span></p></td><td class="confluenceTd"><p><span><span>CTRP is using the International Standards Organization country codes:</span></span><span> </span></p><p><a href="https://www.iso.org/obp/ui/#search" class="external-link" rel="nofollow"><span><span>https://www.iso.org/obp/ui/#search</span></span></a><span> </span></p></td></tr><tr class=""><td class="confluenceTd"><p><strong><span><span>Study Subject Zip Code</span></span></strong><span> </span></p></td><td class="confluenceTd"><p><span><span>Enter the study subject’s zip code. </span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>C</span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>C</span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>Required if the Study Subject Country is the US, US territories and outlying islands.</span></span><span> </span></p><p><span><span>Must be in a 5 digit or </span><span>9 digit</span><span> (DDDDD-DDDD) format</span></span><span> </span></p></td></tr><tr class=""><td class="confluenceTd"><p><strong><span><span>Registration Date</span></span></strong><span> </span></p></td><td class="confluenceTd"><p><span><span>Enter the date that the </span><span>subject was reg</span></span><span><span>istered on the study.</span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>R</span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>R</span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>User Interface format: MM/DD/YYYY</span></span><span> <br/></span><span><span>REST format: YYYY-MM-DD</span></span><span> <br/></span><span><span>Batch Upload format: YYYYMMDD</span></span><span> </span></p></td></tr><tr class=""><td class="confluenceTd"><p><strong><span><span>Disease</span></span></strong><span> </span></p></td><td class="confluenceTd"><p><span><span>Click </span></span><strong><span><span>Look </span><span>Up</span></span></strong><span><span>, and</span><span> follow the instructions in </span></span><a href="https://wiki.nci.nih.gov/display/CTRPdoc/Selecting+Diseases+for+Study+Subject+Records" rel="nofollow"><span><span>Selecting Diseases for Study Subject Records</span></span></a><span><span>.</span></span><span> </span></p><p><span><span>Note: For ICD-O-3, CTRP uses a hybrid model with the codes from IACR and the codes in NCI SEER that are not available in IACR.</span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>R</span></span><span> </span></p></td><td class="confluenceTd"><p><span> </span></p></td><td class="confluenceTd"><p><strong><span><span>Partial Subject:</span></span></strong><span> </span></p><p><strong><span><span>Disease </span></span></strong><span><span>is </span></span><span><span>not </span><span>required</span></span><span><span>.</span></span><span> </span></p><p><strong><span><span>ICD-O-3: </span></span></strong><span><span>If </span></span><strong><span><span>Disease</span></span></strong><span><span> is reported, </span></span><strong><span><span>Site </span></span></strong><span><span>is also </span><span>required</span><span>.</span></span><span> </span></p><p><span> <br/></span><strong><span><span>Study Subject:</span></span></strong><span> </span></p><p><strong><span><span>Disease Code </span></span></strong><span><span>is </span><span>required</span><span> for all trial types.</span></span><span> </span></p><p><strong><span><span>ICD-O-3: Disease </span></span></strong><span><span>and</span></span><strong><span><span> Site </span></span></strong><span><span>are </span><span>required</span><span>.</span></span><span> </span></p></td></tr><tr class=""><td class="confluenceTd"><p><strong>Disease Site</strong></p></td><td class="confluenceTd"><p><span><span>Click </span></span><strong><span><span>Look </span><span>Up</span></span></strong><span><span>, and</span><span> follow the instructions in </span></span><a href="https://wiki.nci.nih.gov/display/CTRPdoc/Selecting+Sites+for+Study+Subject+Records+Using+ICD-O-3+Codes" rel="nofollow"><span><span>Selecting Sites for Study Subject Records Using ICD-O-3 Codes</span></span></a><span><span>.</span></span><span> </span></p><p><span><span>Site Code information is available at:</span></span><span> </span></p><p><a href="http://www.iacr.com.fr/index.php?option=com_content&view=category&layout=blog&id=100&Itemid=577" class="external-link" rel="nofollow"><span><span>http://www.iacr.com.fr/index.php?option=com_content&view=category&layout=blog&id=100&Itemid=577</span></span></a><span> </span></p><p><span><span>Note: CTRP uses a hybrid model with the codes from IACR and the codes in NCI SEER that are not available in IACR.</span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>C</span></span><span> </span></p></td><td class="confluenceTd"><p><span> </span></p></td><td class="confluenceTd"><p><strong><span><span>Partial Subject:</span></span></strong><span> </span></p><p><strong><span><span>Site </span></span></strong><span><span>is </span></span><span><span>not </span><span>required</span></span><span><span>.</span></span><span> </span></p><p><strong><span><span>ICD-O-3: </span></span></strong><span><span>If </span></span><strong><span><span>Site</span></span></strong><span><span> is reported, </span></span><strong><span><span>Disease</span></span></strong><span><span> is also </span><span>required</span><span>.</span></span><span> </span></p><p><span> <br/></span><strong><span><span>Study Subject:</span></span></strong><span> </span></p><p><strong><span><span>Site </span></span></strong><span><span>is </span><span>required</span><span> for all trial types. </span></span><span> </span></p><p><strong><span><span>ICD-O-3: Site </span></span></strong><span><span>and</span></span><strong><span><span> Disease </span></span></strong><span><span>are </span><span>required</span><span>.</span></span><span> </span></p></td></tr><tr class=""><td class="confluenceTd"><p><strong><span><span>Participating Site</span></span></strong><span> </span></p></td><td class="confluenceTd"><p><span><span>Select the </span><span>appropriate site</span><span> from the drop-down list.</span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>R</span></span><span> </span></p></td><td class="confluenceTd"><p><span><span>R</span></span><span> </span></p></td><td class="confluenceTd"><p><span> </span></p></td></tr></tbody></table></div><p><span> </span></p><p><span> </span></p><p><br/></p>
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</div>Tate, Ariana (NIH/NCI) [C]2024-02-15T14:14:17ZCopy of Adding Study Subjects - Include v4.6 - ALT 2/13/2024 v2.0Tate, Ariana (NIH/NCI) [C]tag:wiki.nci.nih.gov,2009:page-568459645-22024-03-26T19:58:14Z2024-02-13T21:41:08Z<div class="feed"> <p>
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<p><span style="color: rgb(0,0,0);text-decoration: none;">You can add one or more study subject accrual records for a</span><span style="text-decoration: none;">ny </span><span style="text-decoration: none;">study</span><span style="text-decoration: none;"> t</span><span style="color: rgb(0,0,0);text-decoration: none;">o which you have been granted access.</span></p><p style="text-align: left;"><sup><a style="text-decoration: none;" class="footnote-marker" title="" href="#footnote1" rel="nofollow">1</a> </sup>If necessary, refer to <a href="https://wiki.nci.nih.gov/display/CTRPdoc/Requesting+Permission+to+Submit+Accrual+Data" style="text-decoration: none;" rel="nofollow">Requesting Permission to Submit Accrual Data</a>.</p><p style="text-align: left;">Study subject records include demographic data as well as the disease name.</p><p style="text-align: left;"><strong>How to Add Study Subject Records</strong></p><ol style="text-decoration: none;text-align: left;"><li>Select th<span style="color: rgb(0,0,0);">e study you</span> want to work with by following instructions in <a href="https://wiki.nci.nih.gov/display/CTRPdoc/Searching+for+and+Selecting+Your+Trials" style="text-decoration: none;" rel="nofollow">Searching for and Selecting Your Trials</a>, and clicking the corresponding NCI Trial Identifier link. The Search Study Subject page appears. <br/><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image confluence-content-image-border" draggable="false" height="250" width="867" src="https://wiki.nci.nih.gov/download/attachments/568459645/image-2024-3-26_15-53-32.png?version=1&modificationDate=1711482812426&api=v2" data-image-src="https://wiki.nci.nih.gov/download/attachments/568459645/image-2024-3-26_15-53-32.png?version=1&modificationDate=1711482812426&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="581009541" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="image-2024-3-26_15-53-32.png" data-base-url="https://wiki.nci.nih.gov" data-linked-resource-content-type="image/png" data-linked-resource-container-id="568459645" data-linked-resource-container-version="2" alt=""></span></li><li>Click <strong>Add New Study Subject</strong>.<br/>The Add Study Subject panel appea<span style="color: rgb(0,0,0);">rs right-aligned to the Study Subject page. (Screenshot below displays Subject accrual)</span><br/><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image confluence-content-image-border" draggable="false" width="867" src="https://wiki.nci.nih.gov/download/attachments/568459645/image-2024-3-26_15-55-1.png?version=1&modificationDate=1711482901261&api=v2" data-image-src="https://wiki.nci.nih.gov/download/attachments/568459645/image-2024-3-26_15-55-1.png?version=1&modificationDate=1711482901261&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="581009542" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="image-2024-3-26_15-55-1.png" data-base-url="https://wiki.nci.nih.gov" data-linked-resource-content-type="image/png" data-linked-resource-container-id="568459645" data-linked-resource-container-version="2" alt=""></span></span> <br/> <em><br/><br/></em></li><li><p>Enter t<span style="color: rgb(0,0,0);">he required demographic information in the text fields and drop-down lists<s>.</s> An asterisk (*) indicates a required field. </span></p></li><li><p><span style="color: rgb(0,0,0);">The following table describes the valid values and formats for each field.</span></p><p><span class="confluence-anchor-link" id="CopyofAddingStudySubjectsIncludev4.6ALT2/13/2024v2.0-AccrualDataElementsforCompleteTrials"></span></p><p><br/></p><p><div class="table-wrap"><table class="relative-table wrapped confluenceTable"><colgroup><col style="width: 10.5723505%;"/><col style="width: 32.17536%;"/><col style="width: 9.836807%;"/><col style="width: 7.998572%;"/><col style="width: 31.532232%;"/></colgroup><tbody><tr><th class="confluenceTh"><br/></th><th class="confluenceTh"><br/></th><th colspan="2" rowspan="1" class="confluenceTh"><strong>Required (R)/Conditional (C)</strong></th><th class="confluenceTh"><br/></th></tr><tr><th class="confluenceTh"><strong>Accrual Data Element</strong></th><th class="confluenceTh"><strong>Definition</strong></th><th colspan="1" class="confluenceTh">Subject</th><th class="confluenceTh"><strong>Partial Subject</strong></th><th class="confluenceTh"><strong>Accepted Values</strong></th></tr><tr><th class="confluenceTh"><strong>Study Subject ID</strong></th><td class="confluenceTd"><span style="color: rgb(0,0,0);text-decoration: none;">Enter the unique Patient ID as per the lead organization or the study site where the subject is registered.</span></td><td colspan="1" class="confluenceTd">R</td><td class="confluenceTd">R</td><td class="confluenceTd">Any numeric or alphanumeric value</td></tr><tr><th class="confluenceTh"><strong>Study Subject Birth Date (MM/YYYY)</strong></th><td class="confluenceTd"><p><span style="color: rgb(0,0,0);text-decoration: none;">Enter the subject's month and year of birth in the format </span><strong style="text-decoration: none;text-align: left;"><code>MM/YYYY</code></strong><span style="color: rgb(0,0,0);text-decoration: none;">.</span></p><p><strong><span style="color: rgb(0,0,0);text-decoration: none;">Note: The subject's age reported in CTRP cannot be greater than 125 years.</span></strong></p></td><td colspan="1" class="confluenceTd">R</td><td class="confluenceTd"><br/></td><td class="confluenceTd"><span style="color: rgb(0,0,0);"><span style="text-decoration: none;">Accrual application </span><span style="text-decoration: none;">format: MM/YYYY</span></span><br style="text-decoration: none;text-align: left;"/><span style="color: rgb(0,0,0);"><span style="text-decoration: none;">REST </span><span style="text-decoration: none;">Services</span><span style="text-decoration: none;"> format: </span>Y</span>YYY-MM-DD<br style="text-decoration: none;text-align: left;"/><span style="color: rgb(0,0,0);text-decoration: none;">Batch Upload format: YYYYMM</span></td></tr><tr><th class="confluenceTh"><strong>Study Subject Gender</strong></th><td class="confluenceTd"><span style="color: rgb(0,0,0);text-decoration: none;">Select the sub</span><span style="text-decoration: none;">ject’s </span><span style="text-decoration: none;">biological sex. If biological sex</span><span style="text-decoration: none;"> inform</span><span style="color: rgb(0,0,0);text-decoration: none;">ation is not available, select </span><strong style="text-decoration: none;text-align: left;">Unknown</strong><span style="color: rgb(0,0,0);text-decoration: none;">.</span></td><td colspan="1" class="confluenceTd">R</td><td class="confluenceTd"><br/></td><td class="confluenceTd">Male<br/>Female<br/>Unspecified<br/>Undifferentiated<br/>Unknown</td></tr><tr><th class="confluenceTh"><strong>Study Subject Race</strong></th><td class="confluenceTd"><p><span style="color: rgb(0,0,0);text-decoration: none;">Select one or more values for race. </span></p><p><span style="color: rgb(0,0,0);text-decoration: none;">To select multiple races, select one race, and then press and hold the <strong style="text-decoration: none;text-align: left;">CTRL</strong>/<strong style="text-decoration: none;text-align: left;">CMD</strong> key as you select the other(s).</span></p></td><td colspan="1" class="confluenceTd">R</td><td class="confluenceTd"><br/></td><td class="confluenceTd"><p>American Indian or Alaska Native<br/>Asian<br/>Black or African American<br/>Native Hawaiian or Other Pacific Islander<br/>Not Reported<br/>Unknown<br/>White</p></td></tr><tr><th class="confluenceTh"><strong>Study Subject Ethnicity</strong></th><td class="confluenceTd"><span style="color: rgb(0,0,0);text-decoration: none;">Select a value for ethnicity.</span></td><td colspan="1" class="confluenceTd">R</td><td class="confluenceTd"><br/></td><td class="confluenceTd">Hispanic or Latino<br/>Not Hispanic or Latino<br/>Not Reported<br/>Unknown</td></tr><tr><th class="confluenceTh"><strong>Study Subject Country</strong></th><td class="confluenceTd">Select the study subject's country of residence.</td><td colspan="1" class="confluenceTd">R</td><td class="confluenceTd"><br/></td><td class="confluenceTd"><p><span style="color: rgb(0,0,0);">CTRP is using the International Standards Organization country codes:</span></p><p><span style="color: rgb(153,51,0);"><a href="https://www.iso.org/obp/ui/#search" class="external-link" rel="nofollow">https://www.iso.org/obp/ui/#search</a></span></p></td></tr><tr><th class="confluenceTh"><strong>Study Subject Zip Code</strong></th><td class="confluenceTd"><span style="color: rgb(0,0,0);text-decoration: none;">Enter the study subject’s zip code. </span></td><td colspan="1" class="confluenceTd">C</td><td class="confluenceTd">C</td><td class="confluenceTd"><p style="text-align: left;"><span style="color: rgb(0,0,0);text-decoration: none;">Required if the Study Subject Country is the US, US territories and outlying islands.</span></p><p style="text-align: left;">Must be in a 5 digit or 9 digit (DDDDD-DDDD) format</p></td></tr><tr><th class="confluenceTh"><strong>Registration Date</strong></th><td class="confluenceTd"><span style="color: rgb(0,0,0);text-decoration: none;">Enter the date that the subject was reg</span><span style="text-decoration: none;">istered </span><span style="text-decoration: none;">on</span><span style="text-decoration: none;"> the </span><span style="text-decoration: none;">study</span><span style="text-decoration: none;">.</span></td><td colspan="1" class="confluenceTd">R</td><td class="confluenceTd">R</td><td class="confluenceTd"><p style="text-align: left;"><span style="color: rgb(0,0,0);"><span style="text-decoration: none;">User Interface</span><span style="text-decoration: none;"> format: </span><span style="text-decoration: none;">MM/DD/YYYY</span></span><br style="text-decoration: none;text-align: left;"/><span style="color: rgb(0,0,0);">REST format: YYYY-MM-DD</span><br style="text-decoration: none;text-align: left;"/><span style="color: rgb(0,0,0);"><span style="text-decoration: none;">Batch Upload format: YYYYMM</span><span style="text-decoration: none;">DD</span></span></p></td></tr><tr><th class="confluenceTh"><span style="color: rgb(0,0,0);"><strong>Disease</strong></span></th><td class="confluenceTd"><p><span style="color: rgb(0,0,0);"><span style="text-decoration: none;">Click </span><strong style="text-decoration: none;text-align: left;">Look Up</strong><span style="text-decoration: none;">, and follow the instructions in </span><a style="text-decoration: none;text-align: left;" href="https://wiki.nci.nih.gov/display/CTRPdoc/Selecting+Diseases+for+Study+Subject+Records" rel="nofollow">Selecting Diseases for Study Subject Records</a><span style="text-decoration: none;">.</span></span></p><p><span style="color: rgb(0,0,0);text-decoration: none;">Note: For ICD-O-3, CTRP uses a hybrid model with the codes from IACR and the codes in NCI SEER that are not available in IACR.</span></p></td><td colspan="1" class="confluenceTd"><span style="color: rgb(0,0,0);">R</span></td><td class="confluenceTd"><br/></td><td class="confluenceTd"><p style="text-align: left;"><u><strong>Partial Subject:</strong></u></p><p style="text-align: left;"><strong>Disease </strong>is <u>not required</u>.</p><p style="text-align: left;"><strong>ICD-O-3: </strong>If <strong>Disease</strong> is reported, <strong>Site </strong>is also required.</p><p style="text-align: left;"><br/><u><strong>Study Subject:</strong></u></p><p style="text-align: left;"><strong>Disease Code </strong>is required for all trial types.</p><p style="text-align: left;"><strong>ICD-O-3: Disease </strong>and<strong> Site </strong>are required.</p></td></tr><tr><th colspan="1" class="confluenceTh"><span style="color: rgb(0,0,0);"><strong>Site <strong style="text-decoration: none;text-align: left;">(for ICD-O-3 Disease Codes)</strong></strong></span></th><td colspan="1" class="confluenceTd"><p>Click <strong>Look Up</strong>, and follow the instructions in <a href="https://wiki.nci.nih.gov/display/CTRPdoc/Selecting+Sites+for+Study+Subject+Records+Using+ICD-O-3+Codes" style="text-decoration: none;" rel="nofollow">Selecting Sites for Study Subject Records Using ICD-O-3 Codes</a>.</p><p>Site Code information is available at:</p><p><a href="http://www.iacr.com.fr/index.php?option=com_content&view=category&layout=blog&id=100&Itemid=577" class="external-link" rel="nofollow">http://www.iacr.com.fr/index.php?option=com_content&view=category&layout=blog&id=100&Itemid=577</a></p><p><span style="color: rgb(0,0,0);text-decoration: none;">Note: CTRP uses a hybrid model with the codes from IACR and the codes in NCI SEER that are not available in IACR.</span></p></td><td colspan="1" class="confluenceTd">C</td><td colspan="1" class="confluenceTd"><br/></td><td colspan="1" class="confluenceTd"><p style="text-align: left;"><u><strong>Partial Subject:</strong></u></p><p style="text-align: left;"><strong>Site </strong>is <u>not required</u>.</p><p style="text-align: left;"><strong>ICD-O-3: </strong>If <strong>Site</strong> is reported, <strong>Disease</strong> is also required.</p><p style="text-align: left;"><br/><u><strong>Study Subject:</strong></u></p><p style="text-align: left;"><strong>Site </strong>is required for all trial types. </p><p style="text-align: left;"><strong>ICD-O-3: Site </strong>and<strong> Disease </strong>are required.</p></td></tr><tr><th class="confluenceTh"><strong>Participating Site</strong></th><td class="confluenceTd">Select the appropriate site from the drop-down list.</td><td colspan="1" class="confluenceTd">R</td><td class="confluenceTd">R</td><td class="confluenceTd"><br/></td></tr><tr><th class="confluenceTh"><strong>Study Subject method of payment</strong></th><td class="confluenceTd"><span style="color: rgb(0,0,0);text-decoration: none;">Select the appropriate payment method.</span></td><td colspan="1" class="confluenceTd"><br/></td><td class="confluenceTd"><br/></td><td class="confluenceTd"><p>Private Insurance<br/>Medicare<br/>Medicare and Private Insurance<br/>Medicaid<br/>Medicaid and Medicare<br/>Military or Veterans Sponsored, NOS<br/>Military Sponsored (Including CHAMPUS & TRICARE)<br/>Veterans Sponsored<br/>Self-Pay (No Insurance)<br/>No Means of Payment (No Insurance)<br/>Managed Care<br/>State Supplemental Health Insurance<br/>Other<br/>Unknown</p></td></tr></tbody></table></div></p><p><strong> </strong></p></li><li>Click <strong>Save</strong>.<br/>The study subject record appears in the List of Study Subjects.</li></ol><p style="margin-left: 40.0px;"><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image confluence-content-image-border" draggable="false" width="867" src="https://wiki.nci.nih.gov/download/attachments/568459645/image-2024-3-26_15-56-45.png?version=1&modificationDate=1711483005380&api=v2" data-image-src="https://wiki.nci.nih.gov/download/attachments/568459645/image-2024-3-26_15-56-45.png?version=1&modificationDate=1711483005380&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="581009544" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="image-2024-3-26_15-56-45.png" data-base-url="https://wiki.nci.nih.gov" data-linked-resource-content-type="image/png" data-linked-resource-container-id="568459645" data-linked-resource-container-version="2" alt=""></span></p><p>For Co<span style="color: rgb(0,0,0);">mplete</span><span style="color: rgb(0,0,0);"> studies, lead organizations report all subjects accrued for the study (both in the lead organization and in all participating sites). For Abbreviated studies, each participating site reports the number of its own accruals (accrual count) only. </span></p><p style="text-align: left;"><span style="color: rgb(0,0,0);">---</span></p><p style="text-align: left;"><br/></p><ol class="display-footnotes" style="text-decoration: none;text-align: left;"><li><span style="color: rgb(0,0,0);">If your organization currently reports subject accrual information for studies to CTEP or DCP via the CDUS/OPEN systems, continue to report subject accrual information via CDUS/OPEN. The NCI will manage the transfer of subject accrual data for CDUS/OPEN studies internally. Otherwise, report your organization's subject accrual data to CTRP.</span></li></ol>
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