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This page tree describes how to abstract and edit the administrative details of clinical trials.
About Administrative Data
You can edit or add most trial-related administrative information except identifiers that the system generates, such as the NCI Trial Identifier.
Administrative data for trials comprises the following information:
- General trial details
- NCI-specific information
- Regulatory information
- Human subject safety
- Trial IND/IDE
- Trial status
- Trial funding
- Participating sites
- Collaborators
- Trial-related documents
After a trial has been accepted, if you log in with an appropriate role, the Administrative Data menu contains an option for each of the above categories.
The trial summary remains displayed at the top of each page throughout abstraction.
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When you have completed abstracting all trial information on a given page, be sure to click the Save button at the bottom of each page before you proceed to another task. |
| Info | ||
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| Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data. |
Abstracting General Trial Details
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| MultiExcerptName | abstractgeneral |
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General trial details include the following main categories of data:
- ClinicalTrials.gov XML Required indicator (displayed for Complete trials only)
- Trial title
- Trial description
- Other identifiers
- Lead organization/Principal investigator
- Sponsor Responsible party (Complete trials that require an XML document for submission to ClinicalTrials.gov only)
- Central contact
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| Info | ||
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Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data. |
Abstracting Trial Descriptions, Titles, and Identifiers
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| MultiExcerptName | abstracttitle |
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How to Abstract Trial Descriptions, Titles, and Identifiers
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On the Administrative Data menu, click General Trial Details.
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Field Label
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Trial Category (Study Source)
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Description/Instructions
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ClinicalTrials.gov XML required?
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Complete
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Select the appropriate option to indicate whether an XML document is required to register the trial with ClinicalTrials.gov.
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Acronym
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Complete and Abbreviated
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Type the abbreviation (initial letters) by which the trial is known.
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Official Title*
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Complete and Abbreviated
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Ensure that the title is accurate and complete (as it appears in the Protocol document). Make any necessary changes or additions.
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Complete and Abbreviated
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If you discover an error that does not fall into the Spelling/Format category, next to Category, select Other, enter the corrected title, and then click Add Alternate Title.
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Keywords
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Complete and Abbreviated
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| Info |
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Although Keywords are included in Administrative abstraction, any changes to them (e.g., via an update from ClincialTrials.gov or the CTRP Registration user interface) require Scientific Acknowledgement. |
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Lead Organization Trial Identifier*
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Complete and Abbreviated
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Enter the ID exactly as it appears in the Protocol document. For Inter-Group trials, type the Lead Group’s trial number. For multi-site trials that have no assigned single center, use the protocol ID.
Example: NSABP-B-40
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ClinicalTrials.gov Identifier
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Complete and Abbreviated
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Enter the trial identifier assigned by ClinicalTrials.gov.
Provide the exact number, including the ClinicalTrials.gov prefix. Example: NCT00012345
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CTEP Identifier
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Complete
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Optionally, in the CTEP Identifier field, type the trial identifier assigned by the Clinical Therapy Evaluation Program.
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DCP Identifier
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Complete
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Optionally, in the DCP Identifier fields, type the trial identifier assigned by the Division of Cancer Prevention.
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Other Trial Identifier
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Complete and Abbreviated
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Make changes as necessary, and then click Done.
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When you save changes to the trial, the system checks the ClinicalTrials.gov Identifier you entered to ensure that no other registered trial has the same one. The system displays an error message if it finds another trial with the same ClinicalTrials.gov Identifier. If this occurs, check the number you entered and try again. |
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Do one of the following to continue:
If the trial that you are abstracting is an Abbreviated trial, click Save
- or -
If the trial that you are abstracting requires an XML document for submission to ClinicalTrials.gov, complete the Sponsor and Responsible Party and Central Contact sections.
- or -
If the trial that you are abstracting does not require an XML document for submission to ClinicalTrials.gov, complete the Central Contact section.
Abstracting Sponsors and Responsible Parties
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| MultiExcerptName | abstractsponsors |
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The Responsible Party can be either a sponsor or a principal investigator (PI). The term "responsible party" is either of the following:
- Sponsor of the clinical trial (as defined in 21 CFR 50.3 or successor regulation)
- or - - Principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements for the submission of clinical trial information.
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The system will not display this section until you indicate that you require an XML document. |
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How to Complete the Sponsor/Responsible Party Section
In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
Instructions for recording Sponsors/Responsible Parties
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Field Label
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Description/Instructions
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Sponsor*
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If the Sponsor/Responsible Party is the Principal Investigator, complete the Lead Organization/Principal Investigator section before the Sponsor/Responsible Party section. |
Click Look Up Sponsor and search for the organization as per the instructions in Searching for Organizations.
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Responsible Party*
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Indicate the party who is responsible for the trial. Select one of the following options:
Sponsor - Name of primary organization that oversees implementation of study and is responsible for data analysis. For applicable clinical trials, sponsor is defined in 21 CFR 50.3. For further elaboration on the definition of Sponsor with respect to responsible party, see http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf.
- Principal Investigator - Primary medical researcher in charge of carrying out a clinical trial's protocol.
- Sponsor-Investigator - Responsible party is both the sponsor and the investigator.
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Investigator*
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If the Responsible Party is the Principal Investigator, this field is pre-populated with the name you entered for the Principal Investigator in the Lead Organization/Principal Investigator section.
If the Responsible Party is the Sponsor-Investigator, this field is pre-populated with the name you entered for the Principal Investigator in the Lead Organization/Principal Investigator section. To change the investigator's name, click Look Up Sponsor, and follow the instructions in Searching for Persons.
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Investigator Title*
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This field is pre-populated. Enter a new title in the field provided if other than Principal Investigator.
Investigator Affiliation*
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This field is pre-populated with the organization you entered as Sponsor.
If the Responsible Party is the Principal Investigator, you can change the affiliated organization. To change the investigator's affiliation, click Look Up Organization, and follow the instructions in Searching for Organizations.
Abstracting Central Contacts
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| MultiExcerptName | abstractcontacts |
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How to Complete the Central Contacts Section
In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. All central contact information is optional.
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A central contact may be a specific person, or it may be a generic title or role rather than a person. For example, the central contact may be “clinical study office,” “director of the clinical study department,” etc. |
Field Label | Description/Instructions |
|---|---|
Personal Contact | If the sponsor is a particular person rather than a generic contact, click Look Up Person, and follow the instructions in Searching for Persons . If no personal contact is provided, complete the information for a generic contact instead. |
Generic Contact | If the sponsor contact is not linked to a particular person, click Look Up Generic Contact, and follow the instructions in Searching for Persons to record the responsible contact’s information. |
Email Address | Enter the contact’s main email address. |
Phone Number | Enter the contact’s main contact phone number. |
Abstracting Collaborators
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| MultiExcerptName | abstractcollaborator |
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You can associate, or link, collaborating organizations with the trial you are abstracting. Collaborator information is included in the Protocol document or in the uploaded Participating Sites document. It is optional for Abbreviated trials.
To delete a previously linked collaborator, see Deleting Collaborators From a Trial.
| Info | ||
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| Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data. |
Linking Collaborators to a Trial
How to Link Collaborators to a Trial
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From the Functional Role drop-down list, select the collaborator’s role in the trial. The following table lists functional role values.
Valid values for functional roles
Functional Role | Definition |
|---|---|
Funding Source | Source of the funding mechanism |
Agent Source | Source of drugs used in the trial |
Laboratory | Clinical research workplace |
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Deleting Collaborators From a Trial
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If a collaborator currently linked to the trial you are abstracting is incorrect, you can delete it from the trial.
How to Delete a Collaborator From a Trial
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
- On the Administrative Data menu, click Collaborators. The Collaborators page appears.
- To disassociate the collaborator from the trial, click the Delete icon, and then confirm the action in the pop-up window.
Editing Collaborator Roles
If the role of a collaborator currently linked to the trial you are abstracting is incorrect, you can change the functional role.
How to Edit Collaborator Roles
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
- On the Administrative Data menu, click Collaborators. The Collaborators page appears.
- To change the collaborator’s role in the trial, click the Edit icon. The Collaborator page displays the current collaborator organization name, and current functional role.
- From the Functional Role drop-down list, select the appropriate role.
- Click Save.
Abstracting Human Subject Safety
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| MultiExcerptName | abstractsafety |
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| Info | ||
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Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data. |
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You will need the IRB approval document for a single site to abstract this category of information. The only field that you are required to complete in this section is the Board Approval Status. Other fields are either optional or non-editable. The latter are indicated by gray fields. |
Some fields in this section are optional, and some may be required only when you have selected certain attributes in preceding fields. For example, if the Board Approval Status is "Submitted, exempt", the Board Name, Board Affiliation, and Board Contact fields are mandatory, but the Board Approval Number is optional.
The following table provides a matrix of field requirement dependencies.
Matrix of field requirements
Board Approval Status | Board Approval Number | Board Name | Board Affiliation | Board Contact |
|---|---|---|---|---|
Submitted, approved | Mandatory | Mandatory | Mandatory | Mandatory |
Submitted, exempt | Optional | Mandatory | Mandatory | Mandatory |
Submission not required | Optional | Optional | Optional | Optional |
How to Abstract Human Subject Safety Information
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Submitted, Approved - IRB approval has been requested and obtained
Submitted, Exempt - IRB has granted an exemption in response to the approval request
Submission Not Required - Study does not require human subjects review
Submitted, Pending - Study is pending IRB review
Submitted, Denied - IRB has denied approval for the study
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If you selected anything other than Submission Not Required, continue with the next fields. Otherwise you are finished with human subject safety abstraction.
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The Board Approval Status must correlate with the current Trial Status as follows:
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In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field for Complete trials.
Field Label | Description/Instructions |
|---|---|
Board Approval Number* | If the trial has been submitted and approved, type the number assigned to the protocol by the human subjects review board in the field. If the number does not appear in the IRB approval document, enter the date. |
Board Name* | Click Look Up to search for and select the Board name. If the name is not listed, register it with the CTRO. See Searching for Organizations . |
Board Affiliation | If the status is other than Submission Not Required, enter the name of the affiliated organization. |
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To save the details you have abstracted, click Save.
Abstracting INDs and IDEs
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| MultiExcerptName | abstractind |
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The choice of values for some fields in this section depend on values that you have selected in preceding fields. For example, if the IND/IDE Type is "IND", the Grantor must be either "CDER" or "CBER". Further, if the Grantor is either "CDER" or "CBER", and the Holder type is anything other than "NIH" or "NCI", NIH Institution / NCI Division/Program names are not available for selection.
| Info | ||
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Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data. |
How to Abstract IND/IDE Information
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In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
Field Label | Description/Instructions |
|---|---|
IND/IDE Type* | Indicate the type of protocol. |
Number* | Type the IND/IDE number. |
Grantor* | Select the grantor from the drop-down list. Valid values are as follows:
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Holder Type* | Select the holder type from the drop-down list. |
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- If you selected any value other than NIH or NCI, skip the next step.
- or - - If you selected either NIH or NCI for the Holder Type, proceed to the next step.
In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
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Field Label
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Description/Instructions
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NIH Institution / NCI Division/Program*
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Expanded Access Indicator*
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Indicate whether or not the drug or device is available outside any clinical trial protocol.
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Expanded Access Status*
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If you selected YES in the Expanded Access Indicator field, select the status of the drug or device access from the field if changes have been requested and information provided. Valid values are as follows:
- Available - Expanded access is currently available for this treatment.
- No longer available - Expanded access was available for this treatment previously but is not currently available and will not be available in the future.
- Temporarily not available - Expanded access is not currently available for this treatment, but is expected to be available in the future.
- Approved for marketing - This treatment has been approved for sale to the public.
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Exempt Indicator
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If the trial is exempt from IND/IDE regulation, select Yes.
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Abstracting NCI-Specific Information
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| MultiExcerptName | abstractnci |
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NCI-Specific Information applies to Complete and Abbreviated trials. For Abbreviated trials, indicate whether or not the trial is Industrial.
| Info |
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Trial categories are now referred to as Study Sources. Refer to http://cancercenters.cancer.gov/GrantsFunding/eData for further information about terminology for NCI-Specific and Data Table 4 information. |
Included in this section is the option, for certain trials, to include them in, or exclude them from, the batch of trials that CTRP sends to ClinicalTrials.gov via FTP nightly.
| Info | ||
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Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial information. |
How to Abstract NCI-Specific Information
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The following factors determine which fields appear on this dialog box:
- If the lead organization for the trial belongs to an organization family, the Program Code field is available. The Program Code field lists all program codes available for that organization family.
- CTRP does not send Abbreviated trials in the batch files, and therefore does not display the option to indicate whether to send the trial.
- For a Complete trial that has been sent to ClinicalTrials.gov in the batch files previously, CTRP does not display the option to indicate whether to send the trial in the future.
- For a Complete, NCI-sponsored trial, CTRP displays the option to indicate whether to send the trial in the future and the Comments field. The default setting for this option depends on whether the trial has been sent to ClinicalTrials.gov previously:
- For an original submission (which therefore has not been sent to ClinicalTrials.gov previously), the option to indicate whether to send the trial defaults to Yes, but CTRP displays the option to exclude the trial in the future.
- For a trial that may have been updated and that had not been sent to ClinicalTrials.gov when submitted originally, it defaults to No, but CTRP displays the option to send the trial in the future.
In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
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Field Label
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Description/Instructions
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Reporting Data Set Method*
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Specifies how CDUS accruals are submitted to CTEP. Select one of the following methods used for the principal investigator summary report:
- Abbreviated - Requires minimal subset of data for reporting (for example, demographics)
- Complete - Larger set of data (for example, includes outcomes)
- AE (Adverse Events). Adverse events statistics are reported
| Info |
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This field does not reflect the trial category, even though it uses similar terminology. |
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Data Table 4 Funding Category
Select one of the following trial types based on the role/responsibility/participation in the study.
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For more information, refer to http://cancercenters.cancer.gov/GrantsFunding/eData#dt4 for further information.
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Data Table 4 Funding Sponsor/Source
To add a sponsor, click Add Sponsor and search for the name of the external sponsor or funding source as defined by the Data Table 4 report. (See Searching for Organizations .)
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To delete an existing sponsor, click Delete Sponsor. You can not "undo" the deletion but you can add the sponsor back if necessary.
Refer to http://cancercenters.cancer.gov/GrantsFunding/DataGuide#dt4 and http://cancercenters.cancer.gov/GrantsFunding/eData#dt4 for further information about specific Funding Sponsors.
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Because most Abbreviated trials are Industrial, the default value during trial registration is "YES". For Consortia trials, select one of the other values.
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Program Code
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The Program Code field lists all program codes available for the organization family of the lead organization. Select one or more program codes. The program codes are generally entered by the trial submitter.
To view or modify a different family's program codes, refer to the Registration Site Administration chapter of the Registration User's Guide.
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For Complete trials, select one of the following to indicate whether to send the trial information to ClinicalTrials.gov in the automated nightly batch updates (via FTP):
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If you select Yes, the CTRP system sends the information to ClinicalTrials.gov. If PRS indicates to the CTRP system that it processed the trial successfully, the CTRP system does not display this option in the future for this trial. |
For further information about this field, see Conditions for Sending Trial Information to ClinicalTrials.gov.
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Industrial? Values
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For Abbreviated trials, indicate whether the trial is an Industrial trial or other category, according to the Data Table 4 Category values below. The Consortia Trial Indicator is internal to the CTRP system.
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Conditions for Sending Trial Information to ClinicalTrials.gov
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Following are the inclusion criteria the system uses to determine the set of CTRP trials to send to ClinicalTrials.gov:
The trial is NCI Sponsored. Trials are funded under an N01/N02 contract or have an IND held by CTEP, where NCI is listed as the sponsor.
AND- Has been fully abstracted.
AND - The Send Trial Information to ClinicalTrials.gov field is set to Yes.
The System will exclude from sending all trials that meet one or more of the following criteria:
- Observational trials.
OR - Industrial trials.
OR - Trials with the Send Trial Information to ClinicalTrials.gov field set to No.
OR - CCR trials.
Abstracting Participating Sites
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| MultiExcerptName | abstractsite |
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Trials are conducted in participating sites. You must provide information about the site itself (organization), the investigator(s), and primary contacts (if a central contact is not provided). Optionally, you can include contact information for a person’s title (functional role) rather than a person’s name. When you add a participating site to a trial, link (associate) an organization, site, investigator(s), and primary site contact information to it.
| Tip |
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Providing a site contact is optional if you provide a central contact instead. |
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The system assigns investigators and primary contacts a status code that corresponds to the person’s/role’s curation status. |
Information about participating sites can be included in the protocol document or in the Participating Sites document.
| Info | ||
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Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data. |
How to Abstract Participating Site Information
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On the Administrative Data menu, click Participating Sites. The Participating Sites page appears.
Click Add.
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The Participating Sites page displays three tabbed sections: Participating Site, Investigators, and Contact. The Participating Sites tab is displayed by default.
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You must abstract the Participating Site information in the order indicated by the tabbed pages. |
In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
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Field Label
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Description/Instructions
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Organization Name*
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Click Look Up and follow the instructions in Searching for Organizations . For Complete trials, the City, State, Country, and Zip/Postal Codes fields are populated with the organization information you selected.
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Local Trial Identifier*
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Enter the site trial identifier.
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Site Recruitment Status*
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- Optionally, to view the trial’s recruitment status history, click History.
- Select the status from the drop-down list. Valid ClinicalTrials.gov recruitment values are provided in Site Recruitment Status Definitions.
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Site Recruitment Status Date*
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Enter the date that the status was recorded. The date must be the current date or earlier.
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If the lead organization or participating site is a member of a Cancer Center family of organizations, enter the accrual number.
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Date Opened for Accrual
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If applicable, enter the date that the trial was opened for accrual.
| Note |
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You must enter a date here if you also provide a Date Closed for Approval date. |
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Date Closed for Accrual
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If applicable, enter the date that the trial was closed for accrual.
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If you enter a date here you also must provide a Date Opened for Approval date. The Date Closed for Accrual can not be in the future. |
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Click Save.
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Click the Investigators tab.
The Investigators tab displays the trial investigators that may have been added during trial submission or abstraction.
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If you want to indicate that an investigator is the primary contact, click the Set as Site Primary Contact icon next to this investigator's record.
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You will not be able to complete the abstraction if you do not indicate the primary contact. |
Click the Contacts tab.
The Participating Sites page displays the Contacts tab.
| Note |
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You must link a Participating Site to the trial before abstracting the site PI and contact information. You can add a contact by providing a person’s name (i.e., someone who is associated with the trial itself), or you can add a generic contact (i.e., someone who is associated with the site but not necessarily the trial) by providing a person’s title (functional role). You can not provide both types of contacts in the same record. |
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In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
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Field Label
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Description/Instructions
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Enter the contact’s primary telephone number (as 123-456-7890), including an extension if provided.
You must provide either the contact's phone number or email address. You can provide both if the information is available.
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Email Address
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Type the contact’s primary email address.
You must provide either the contact's phone number or email address. You can provide both if the information is available.
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Abstracting Participating Site Information for Complete Trials
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How to Abstract Participating Site Information for Complete Trials
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Click Add. The Participating Sites page displays three tabbed sections: Participating Site, Investigators, and Contact. The Participating Sites tab is displayed by default.
| Info | ||
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You must abstract the Participating Site information in the order indicated by the tabbed pages. |
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On the Participating Sites tab, next to the Organization Name field, click Look Up and follow the instructions in Searching for Organizations .
The City, State, Country, and Zip/Postal Codes fields are populated with the organization information you selected.
In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
Field Label | Description/Instructions |
|---|---|
Local Trial Identifier | Enter the site trial identifier. |
Site Recruitment Status* | Select the status from the drop-down list. See Site Recruitment Status Definitions . |
Site Recruitment Status Date* | Enter the recruitment status date. The date must be the current date or earlier. |
| Site Recruitment Status Comments | Enter one or more comments about the site recruitment status. |
Target Accrual Number | If the lead organization or participating site is a member of a Cancer Center family of organizations, type the accrual number. |
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If you want to indicate that an investigator is the primary contact, click the Set as Site Primary Contact icon next to this investigator's record.
| Note |
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You will not be able to complete the abstraction if you do not indicate the primary contact. |
Click the Contacts tab.
The Participating Sites page displays the Contacts tab.
| Note |
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You must link a Participating Site to the trial before abstracting the site PI and contact information. You can add a contact by providing a person’s name (i.e., someone who is associated with the trial itself), or you can add a generic contact (i.e., someone who is associated with the site but not necessarily the trial) by providing a person’s title (functional role). You can not provide both types of contacts in the same record. |
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In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
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Field Label
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Description/Instructions
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Enter the contact’s primary telephone number (as 123-456-7890), including an extension if provided.
You must provide either the contact's phone number or email address. You can provide both if the information is available.
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Email Address
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Type the contact’s primary email address.
You must provide either the contact's phone number or email address. You can provide both if the information is available.
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Site Recruitment Status Definitions
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Adding Generic Participating Site Contacts
How to Add a Generic Participating Site Contact
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Next to the Generic Contact field, click Look Up Generic Contact.
The Select Generic Contact window appears.
| Tip |
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You can search for an existing generic contact. To do so, enter part or all of the generic contact's role, and then click Search. |
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Abstracting Participating Site Information for Abbreviated Trials
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How to Abstract Participating Site Information for Abbreviated Trials
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Click Add. The Participating Sites page displays three tabbed sections: Participating Site, Investigators, and Contact. The Participating Sites tab is displayed by default.
In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
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Field Label
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Description/Instructions
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Organization Name*
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Click Look Up and follow the instructions in Searching for Organizations .
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Local Trial Identifier*
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Enter the site trial identifier.
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Site Recruitment Status*
- Optionally, to view the trial’s recruitment status history, click History.
- Select the status from the drop-down list. Valid ClinicalTrials.gov recruitment values are provided in Site Recruitment Status Definitions.
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Site Recruitment Status Date
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Enter the date that the status was recorded. The date must be the current date or earlier.
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If the lead organization or participating site is a member of a Cancer Center family of organizations, enter the accrual number.
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Date Opened for Accrual
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If applicable, enter the date that the trial was opened for accrual.
| Note |
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You must enter a date here if you also provide a Date Closed for Approval date. |
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Date Closed for Accrual
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If applicable, enter the date that the trial was closed for accrual.
| Note |
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If you enter a date here you also must provide a Date Opened for Approval date. |
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Editing and Deleting Participating Site Records
If a participating site record currently associated with the trial you are abstracting is incorrect, you can edit or delete the site.
How to Edit or Delete a Participating Site From a Trial
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To delete a participating site from the trial, in the Delete column, select the Delete check box, and then click Delete at the bottom of the list of records.
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Confirm that you want to delete the site(s) in the pop-up window.
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Editing and Deleting Participating Site Recruitment Status Records
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How to Edit and Delete Participating Site Recruitment Status Records
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To correct warnings/errors in a record, click the Edit icon.
The Edit Participating Site status dialog box appears.
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Abstracting Regulatory Information
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| MultiExcerptName | abstractregulatory |
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Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data. |
How to Abstract Regulatory Information
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In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field for Complete trials only.
Field Label | Description/Instructions | ||
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Trial Oversight Authority Country* | Select the name of the country in which the oversight authority organization is located. | ||
Trial Oversight Authority Organization Name* | Select the name of the organization that oversees the trial from the drop-down list. | ||
FDA Regulated Intervention Indicator* | Indicate whether the trial is regulated by the FDA by selecting Yes or No.
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Section 801 Indicator* | Indicate whether the FDA-regulated interventional trial is an applicable trial as defined in US Public Law 110-85, Title VIII, Section 801 by selecting Yes or No.
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Delayed Posting Indicator* | Indicate whether the release of trial information on Cancer.gov is being delayed until after an interventional device has been approved or cleared by selecting Yes or No. | ||
Data Monitoring Committee Appointed Indicator | Optionally, indicate whether a data monitoring committee has been appointed for this trial by selecting Yes or No.
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Abstracting Trial Statuses
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| MultiExcerptName | abstractstatus |
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The Trial Status abstraction workflow is slightly different for Super, Administrative, and Scientific Abstractors. Although each of the abstractor roles can change the status transitions, the trial check in/check out behavior varies. See the table in Checking In and Checking Out Trials for details.
Trial Status Abstraction
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How to Abstract Trial Status Information
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In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
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Field Label
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Description/Instructions
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Current Trial Status*
Select the trial’s accrual status from the drop-down list. Valid values are as follows:
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Current Trial Status Date*
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Enter the date on which the current trial status became effective. See Trial Status Date Rules .
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Why Study Stopped
If you selected the Administratively Complete, Withdrawn, or Temporarily Closed to Accrual status, type the reason why the study has ended or is not currently accruing. You can update your comment only for trials that are Temporarily Closed to Accrual. Optionally, enter any comments regarding the trial status.
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Trial Start Date*
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Enter the date on which the trial started, or is expected to start.
Indicate whether the start date is the one on which the trial is expected to start, or the date on which it actually started by selecting Anticipated or Actual. See Trial Status Date Rules .
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Primary Completion Date*
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Enter the date on which the final subject was examined or received an intervention, or the date on which that is expected to happen. Indicate whether the completion date is the one on which the trial is expected to be primarily completed, or the date on which it actually was primarily completed, by selecting Anticipated or Actual. See Trial Status Date Rules .
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Primary Completion Dates are optional in the following cases:
In both cases, the system excludes such trials when submitting XML documents to ClinicalTrials.gov. |
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Completion Date
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Enter the final date on which data was (or is expected to be) collected for the trial. Indicate whether the completion date is the one on which the trial is expected to be completed, or the date on which it actually was completed, by selecting Anticipated or Actual. See Trial Status Date Rules .
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Trial Status Record Abstraction for Super Abstractors
How to Abstract Trial Status Information
- Follow the instructions for abstracting Trial Statuses in Trial Status Abstraction for Admin Abstractors.
Because you can abstract a trial status without checking it out, the system checks out the trial to you. This ensures that you do not invalidate previously validated records.
If the system detects errors, it displays the Trial Status Validation window.
- Click Trial Status History and follow the instructions in Abstracting Trial Status Histories .
Abstracting Trial Status Histories
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| MultiExcerptName | statushistory |
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On the upper right corner of the Trial Status page, click History.
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The system validates all status transitions previously recorded. If one or more status transitions does not conform to the rules provided in Trial Status Transitions, the system displays errors and/or warnings. Please contact your system administrator if this occurs. |
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To add a new interim trial status, click Add New Status and follow the instructions in Abstracting Trial Statuses .
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The Edit Trial Status window displays current trial status information.
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Make the change as necessary, enter a comment, and then click Save. If the system invalidates the new record, correct the errors and save the record.
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To delete a status record, click the Delete icon, and then click Save.
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You must enter a comment any time you change or delete a trial status record. |
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Trial Status Transitions
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| MultiExcerptName | statustransitions |
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Trial Status Rules for Start and Primary Completion Dates
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Abstracting Funding
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| MultiExcerptName | abstractfunding |
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Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data. |
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| title | You can look up grant information in RePORT |
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How to Abstract NIH Grant Information
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On the Administrative Data menu, click Trial Funding. The Trial Funding page appears. The NIH Grant Information section lists any NIH grant records for the trial. If an abstractor deleted one or more grant records previously, the Deleted NIH Grants section lists the deleted grant records.
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To add an NIH Grant record, click Add. The Add/Edit NIH Grant section appears.
In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. All fields are required.
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Field Label
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Description/Instructions
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Funding Mechanism Code
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Type the initial letter and or number in the field and then select the code used to identify areas of extramural research activity from the drop-down list. See Funding Mechanism Codes .
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Click the down arrow in the field, and then use the up and down arrow keys on your keyboard to scroll up and down the drop-down list. When you arrive at the appropriate code, press the Enter key. |
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NIH Institute Code
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Serial Number
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Enter the five- or six-digit serial number.
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NCI Division/Program
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Type the initial letter(s) of the division or program code and then select the code from the drop-down list. See NCI Division and Program Codes for valid values.
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Click Save.
The NIH Grant record you just created is listed in the table.
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To make changes to the record, click the Edit icon (pencil) and make changes on the Add/Edit Grant page.
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To delete the record, select the check box in the Delete column for each record you want to delete, and then click Delete. Or, to delete all records, click Select All, and then click Delete.
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In the confirmation pop-up window, click OK to confirm that you want to delete the record(s).
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In the Provide Reason for Deletion text box, enter the reason for deleting the record, and then click Done.
Abstracting Trial-Related Documents
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| MultiExcerptName | abstractdocs |
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You must include only one of each of the following types of documents for original submission of Complete trials:
Protocol document (complete protocol)
IRB Approval
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Informed consent and participating site documents are optional and can be uploaded if relevant information is not included in the Protocol document. |
You must include only one each of the following types of documents for each submission of trial amendments:
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IRB approval
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Informed consent
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Protocol highlight change
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Participating site documents (if appropriate)
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You are required to supply your documents as Microsoft Word, Adobe PDF, Microsoft Excel, or WordPerfect files.
Adding Documents
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On the Administrative Data menu, click Trial Related Documents.
The Trial Related Documents page appears.
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Click Add.
The Add/Edit Document page appears.
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In the Document Type field, select the type of trial document you want to add to the abstract from the drop-down list. Valid document types are as follows:
- Protocol
- IRB approval
- Participating Sites
- Informed Consent
- Other
- Change Memo Document
- Protocol Highlighted Document
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Click Browse, navigate to the document you want to upload in the File Upload window, and then click Open.
| Info |
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Depending on your operating system, the File Upload window and the Open button may be named something else. |
The Trial Related documents page displays your new document in the table.
Editing and Replacing Documents
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You can edit current trial-related documents by downloading them, editing them, and replacing them.
To delete, rather than edit, documents other than protocol and IRB approval documents, see Deleting Documents.
How to Edit and Replace Trial-Related Documents
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
On the Administrative Data menu, click Trial Related Documents.
The Trial-Related Documents page appears.
To replace a document, click the Edit icon and upload a replacement document as per the instructions below. The replacement document must be of the same type as the original.
The document is replaced and appears in the table. Continue with the steps below only if you want to modify an existing file.
To edit a document, click its file name link, save the file to a location on your local drive, and modify the file as necessary. You can save the modified file with the same name (that is, write over the original), or save it with a new file name.
On the Trial Related Documents page, click the Edit icon in the row of the document you downloaded.
The Add/Edit Document page appears. Note that you are not able to change the document type.
Click Browse, navigate to the document you just edited, and then click Open. Follow your browser/operating system instructions to view or save the document
The Trial Related documents page displays your modified document in the table.
Deleting Documents
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How to Delete Trial-Related Documents
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
On the Administrative Data menu, click Trial Related Documents.
The Trial Related Documents page appears.
Select the Delete check box for each document you want to delete, or, click Select All to select all documents that are candidates for deletion.
Note Check boxes are available only for those document types that can be deleted according to the constraints listed at the top of this page.
Click Delete.
On the confirmation pop-up window, click OK to remove the selected document(s) from the trial.
Enter the reason for deleting the document(s), for example, “Duplicate document” in the text box. The system counts down the character count as you type. The character limit is 200.
Click Done.
