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On the main menu, click Register Industrial/Other Trial. The Register Trial page in Registration appears.
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By default, all sections of the registration form are displayed. To collapse or expand each section individually, click the Collapse or Expand icon on the right side of the section title as shown in the figure above. To collapse all sections, click Collapse All. |
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In the various fields, specify the appropriate information. The following sections describe the fields:
- Recording Trial Identification Information
- Recording Intervention Trial Details
- Recording Non-Intervention Trial Details
- Recording Data Table 4 Information
- Recording Site Recruitment Statuses and Dates
- Uploading Trial-Related Documents
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Be sure to provide information for all fields marked with an asterisk (*). If you cannot complete the registration of a trial in one Registration session, you can save a draft of the trial details you have completed. Later you can return to complete the registration in another session. |
At any time while specifying trial information, consider using one of the buttons described in the following table:
Instructions for registering trials
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Field Label
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Description/Instructions
Save as Draft
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Click to save a draft of the record so that you can complete the registration at another time. You must have provided, at the minimum, both the Lead Organization and Lead Organization Trial Identifier to save a draft.
The system saves your draft, assigns it a unique ID (for tracking purposes), and sends you an email message confirming that the information has been saved. You can end your CTRP Registration Site and retrieve your draft later to complete the registration.
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Review Trial
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Click to initiate the system check for errors and missing information. The system displays the results in a message at the top of the Review Trial Details page. Indicators mark specific fields that you must complete or correct in order to submit the trial.
The Review Trial Details page is read-only. To make changes to the trial data, follow the instructions in Recording Trial Details.
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Recording Trial Identification Information
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Optionally, enter the number assigned to the trial by PRS (ClinicalTrials.gov).
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Recording Interventional Trial Details
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In the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
Instructions for recording Trial Details
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Title*
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Enter the official name of the protocol provided by the study principal investigator or sponsor. (Limit 4000 characters)
For example: "Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Metastatic Adenocarcinoma of the Prostate"
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Trial Type*
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Select Interventional (the default).
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Primary Purpose*
1. Select the primary reason for conducting the trial. The following list provides valid values.
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2. If the primary purpose is Other, enter a detailed description of the trial’s purpose in the text field provided.
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1. Select one of the following reasons for conducting the trial.
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2. If the secondary purpose is Other, enter a detailed description of the trial’s secondary purpose in the text field provided.
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Phase*
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Is this a Pilot?
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Recording Non-Interventional Trial Details
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In the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
Instructions for recording Trial Details
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Title*
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Enter the official name of the protocol provided by the study principal investigator or sponsor.
For example: "Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Metastatic Adenocarcinoma of the Prostate"
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Trial Type*
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Select Non-Interventional.
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Select one of the following trial types:
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Primary Purpose*
1. Select the primary reason for conducting the trial from the following values.
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2. If your trial does not fall into one of these categories, select Other, and note the type of trial in the corresponding text box.
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The text box is displayed only after you have selected Other. |
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Study Model Code*
1. Select the primary strategy for subject identification and follow-up. The following list provides valid values.
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2. If the study model is Other, type a detailed description of the trial’s study model in the text field provided.
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The text field is displayed only after you have selected Other. |
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Time Perspective Code*
1. Select the temporal relationship of observation period to time of subject enrollment. The following list provides valid values.
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2. If the time perspective is Other, type a detailed description of the trial’s time perspective in the text field provided.
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The text field is displayed only after you have selected Other. The limit is 200 characters; the system counts down the character numbers as you type. |
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Select the phase or stage of the clinical trial as defined by the US FDA, from the drop-down list. The following list provides valid values.
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Select N/A for observational and ancillary-correlative trials. |
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Is this a Pilot?
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Site Principal Investigator*
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Click Look Up Person and search for the principal investigator. See Looking Up Registered Persons .
Recording Data Table 4 Information
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Select the organization from the list.
If the sponsor organization is not listed, click Search, and follow the instructions in Searching for Organizations.
The organization you selected is displayed along with an option to delete it.
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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.
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Recording Site-Specific Recruitment Statuses and Dates
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In the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
Instructions for recording Site Recruitment Statuses/Dates
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Field Label
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Description/Instructions
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Site Recruitment Status*
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Select the current stage or state of the trial or study.
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Site Recruitment Status Date*
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Enter the date on which the current trial status became effective. See Trial Status Rules.
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Date Opened for Accrual
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If appropriate, enter the date on which the trial was opened for accrual.
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Date Closed for Accrual
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If appropriate, enter the date on which the trial was closed for accrual.
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Submitting Trial-Related Documents
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When registering Abbreviated trials, you upload the following types of documents:
- IRB Approval
Informed Consent
Upload your documents as Microsoft Word (.doc, .docx, or .docm), Adobe PDF, or WordPerfect files.
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- Next to the document-type field, (e.g., IRB Approval), click Browse.
Navigate to, and select, the appropriate document, and then click Open.
Info Depending on your operating system, you may see a different command name for "Open."
Repeat the steps above for each type of document.
Tip title Adding Multiple "Other" Documents You can upload more than one (1) "Other" document. After you have uploaded the first of your "Other" documents, click the Add More link. A new Other document field is displayed.
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Converting Trial-Related Documents to PDF
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