Page History

Before you begin your review and validation of submitted trial data, open or print the protocol, IRB, consent, and/or other trial-related documents so that you can compare trial details in the document(s) to those displayed in Protocol Abstraction. For instructions, see Editing and Replacing Documents . To facilitate the comparison, you can view and print the Trial Summary Report (TSR), which contains all data as submitted via CTRP Registration. For instructions, see Accessing Trial Summary Reports .

How to Validate Submitted Trials

1. Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
2. On the Trial Identification page, check out the trial. For instructions, see Checking In and Checking Out Trials.
3. Optionally, on the Trial Overview menu, click View TSR to view and print the Trial Summary Report.
4. On the Validation menu, click through each of the trial validation menu options. Review and compare the trial details in the protocol document or other trial-related documents with those displayed on each page.
5. Modify the trial details as necessary.

6. Click Save.

   Note
   title Save your drafts
   The system does not automatically save the changes to trial details that you make while validating trials. If you are not able to complete the trial validation process in your current session and want to save the changes you have made so that you can continue with the validation at another time, be sure to save the information before logging out or navigating to another page. You can also put a trial on hold if validation requires additional information. For instructions, see  Putting Trial Processing On Hold .

7. On the Validation menu, click Trial Validation.
8. Accept or reject the trial by following the instructions in Accepting and Rejecting Trials.

Protocol and IRB documents are required for all Complete trials. Ensure that all required documents have been submitted and that these documents include information required for abstracting trials. For example, the informed consent document must be included in the Protocol document or submitted in a separate file.

A summary of the protocol is required for all Abbreviated trials.

How to Validate Trial-Related Documents

1. Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
2. On the Trial Identification page, check out the trial. For instructions, see Checking In and Checking Out Trials.

3. On the Validation menu, click Trial Related Documents.
   The Trial Related Documents page appears.
   
   

   Note
   title Submit a participating sites document for multi-site trials
   You must submit a participating sites document for a multi-site trial if the participating sites data are not included in the protocol document.

4. Do one of the following to continue:
   
   • To add a new document, click Add and follow the instructions provided in Adding Documents .
   • To modify or replace an existing document, click the Edit icon and follow the instructions provided in Editing and Replacing Documents .

   • To delete a document other than a Protocol or IRB Approval document, click the Delete icon in the Delete column and follow the instructions provided in Deleting Documents.

     Note
     title Document modification rules
     You can add, edit, or delete only those documents that are not required. You only can replace the required ones.

5. If you made any changes, click Save.

Ensure that the relationships between statuses and dates follow the rules provided in the tables and diagrams that follow.

How to Review Trial Status Details

1. Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
2. On the Trial Identification page, check out the trial. For instructions, see Checking In and Checking Out Trials.

3. On the Validation menu, click Trial Status. The Trial Status page appears.
   

4. To view trial status information previously recorded, in the upper right corner of the Trial Status section, click History.

5. 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
   Current Trial Status*	Select the trial’s accrual status from the drop-down list. Valid values are as follows: Include Page Trial Status Definitions - Include v4.4 Trial Status Definitions - Include v4.4
   Current Trial Status Date*	Enter the date on which the current trial status became effective.
   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.
   Trial Start Date*	Enter the date on which the trial started, or is expected to start. See Trial Status Rules. 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.
   Primary Completion Date	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 complete, or the date on which it actually completed, by selecting Anticipated or Actual. Info title Exceptions Primary Completion Dates are optional in the following cases: For non-interventional trials. For DCP trials, if you select N/A as the type. In both cases, the system excludes such trials when submitting XML documents to ClinicalTrials.gov.
   Completion Date	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 complete, or the date on which it actually completed, by selecting Anticipated or Actual. HTML Comment hidden true See https://prsinfo.clinicaltrials.gov/definitions.html.

6. If you made any changes, click Save.
7. If the system displays errors and/or warnings, correct them according to the instructions in Abstracting Trial Status Histories.

How to Validate Funding Details

1. Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
2. On the Trial Identification page, check out the trial. For instructions, see Checking In and Checking Out Trials.
3. On the Validation menu, click Trial Funding.
   The Trial Funding page appears and may display one or more funding records.
   
4. Ensure that no duplicate NIH grant records were registered. If a duplicate exists, use the protocol document to verify which record is correct. If you are unable to determine the correct record, you may contact the trial submitter to request verification.
5. If the submitter determines that one of the records is a duplicate, delete the duplicate by following instructions in the next step.
6. Do one of the following to continue:
   
   • To add funding mechanism information if no records are displayed, click Add and follow the instructions provided in Abstracting Funding.
   • To modify an existing record, click the Edit icon and follow the instructions provided in Abstracting Funding.
   • To delete a record, click the Delete icon in the Delete column. Then, in the Provide Reason for Deletion field that appears, type the reason for deleting the record, and click Done.
7. If you made any changes, click Save.

For Complete trials, ensure that no duplicate IND/IDE records were registered. If a duplicate exists, use the Protocol document to verify which record is correct. If you are unable to determine the correct record, you may contact the trial submitter to request verification.

How to Review Trial Funding Details

1. Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
2. On the Trial Identification page, check out the trial. For instructions, see Checking In and Checking Out Trials.
3. On the Validation menu, click Trial IND/IDE.
   The Trial IND/IDE Information page appears.
   
   
4. Do one of the following to continue:
   
   • To add IDE or IND information if no records are displayed, click Add and follow the instructions provided in Abstracting INDs and IDEs.
   • To modify an existing record, click the Edit icon and follow the instructions provided in Abstracting INDs and IDEs.
   • To delete a record, click the Delete icon.
5. If you made any changes, click Save.

How to Validate Trial Details

1. Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
2. On the Trial Identification page, check out the trial. For instructions, see Checking In and Checking Out Trials.

3. On the Validation menu, click Trial Validation.

4. 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	Instructions
   ClinicalTrials.gov XML required?	See Abstracting General Trial Details .
   Lead Organization Trial ID*	Ensure that the ID matches the one provided in the protocol. Make changes as necessary. See Abstracting General Trial Details .
   ClinicalTrials.gov Identifier Number	See Abstracting General Trial Details .
   Official Title*	Type or correct the trial title as necessary. You can use a maximum of 4000 characters. See Abstracting General Trial Details .
   Trial Phase*	See Abstracting Interventional Trial Design.
   Phase Additional Qualifier	See Abstracting Interventional Trial Design.
   Primary Purpose*	See Abstracting Interventional Trial Design.
   Primary Purpose Other Text (available if Primary Purpose = Other)	See Abstracting Interventional Trial Design.
   Other Identifiers	See Abstracting Interventional Trial Design.
   Lead Organization*	See Searching for Organizations.
   Principal Investigator*	See Searching for Persons.
   Sponsor*	Validate this section if the trial submitter has indicated that an XML document is required to register the trial with ClinicalTrials.gov. Info The ClinicalTrials.gov XML Required indicator (true/false) is displayed on the Validate Trial page. To get there, on the Trial Overview menu, click Trial Identification. See Abstracting General Trial Details .
   Responsible Party*	See Abstracting General Trial Details .
   Responsible Party Email Address*	See Abstracting General Trial Details.
   Responsible Party Phone Number*	See Abstracting General Trial Details .
   Data Table 4 Funding Category	See Abstracting NCI-Specific Information.
   Data Table 4 Funding Source	See Abstracting NCI-Specific Information.
   Program Code	See Abstracting NCI-Specific Information.

5. Do one of the following to continue:
   
   • To save the trial information so that you can continue to validate the trial at a later time, click Save.
     - or -
   • To put the trial on hold, for example, when you require further information from the submitter, click Place on Hold. See Processing On-hold Information.
     - or -
   • To accept or reject the trial, follow the instructions in Accepting and Rejecting Trials.

These instructions pertain to complete trials that require XML documents for submission to ClinicalTrials.gov.

How to Validate Regulatory Information

1. Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
2. On the Trial Identification page, check out the trial. For instructions, see Checking In and Checking Out Trials.
3. On the Validation menu, click Regulatory Information.
   The Regulatory Information page appears.
   
   
4. Follow the instructions provided in Abstracting Regulatory Information.
5. If you made any changes, click Save.

Ensure that the following information is complete and accurate:

• Organization Name
• Local Trial Identifier
• Site Principal Investigator
• Site Recruitment Status
• Site Recruitment Status Date
• Date Opened for Accrual
• Date Closed for Accrual

How to Validate Participating Sites

1. Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
2. On the Trial Identification page, check out the trial. For instructions, see Checking In and Checking Out Trials.
3. On the Validation menu, click Participating Sites.
   The Participating Sites Page appears.
   
4. Do one of the following to continue:
   
   • To add participating sites, click Add and follow the instructions provided in Abstracting Participating Sites.
   • To modify an existing record, click the Edit icon and follow the instructions provided in Abstracting Participating Sites.
   • To delete a record, click the Delete icon.
5. If you made any changes, click Save.

There is little difference between validating an original submission and an amended version other than the trial’s history and access to additional trial-related documents.

For amended trials, you can change additional elements specific to the amendment as follows:

• Amendment date and amendment number on the Trial History page. See Processing Trial History Information .
• Assigned Amendment Reason Code on the Trial History or Trial Validation page.

How to Change an Amendment Reason Code

1. Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
2. On the Trial Identification page, check out the trial. For instructions, see Checking In and Checking Out Trials.
3. On the Validation menu, click Trial Validation, and scroll to the bottom of the Trial Validation page.
   
   
4. In the Amendment Reason Code drop-down list, select a valid reason code. The following table lists valid reason codes.

   Include Page
   Amendment Reason Codes - Include v4.4 Amendment Reason Codes - Include v4.4

5. Click Save.

After you establish that all trial information is correct, accept the trial to make it available for future abstraction.
If the trial contains incorrect information that you can not modify or verify, place the trial on hold. See Putting Trial Processing On Hold for instructions.
If the trial is a duplicate of another in the CTRP database, or is invalid, reject the trial.

Before you accept a trial, verify the following trial characteristics:

• Distinctiveness.

  Footnote

  The CTRP system checks for duplicate trials by ClinicalTrials.gov identifier. However it does not check for duplicate titles or other aspects of the trial. If you find a duplicate trial, decide which is correct as per the Protocol document, and then reject the other. The system displays an error message if it detects that there is an existing trial with the same ClinicalTrials.gov ID when you click Save on the General Trials Details page during validation. In order to save the trial information successfully, you must first change the ClinicalTrials.gov ID.

   Verify that the trial is not a duplicate of one previously registered and accepted in the CTRP.

• Appropriateness. For example, the CTRO accepts only trials submitted by a lead organization, and not a participating site in the case of a multi-site trial with an existing coordination center.

• Completeness. For example, if a given type of document is missing, verify that it is included in another trial document.
• Accuracy. For example, verify that the principal investigator’s information is correct.
• Consistency. For example, verify that the Protocol document is consistent with the submitted trial details.

All required fields must contain information in order to be accepted. Additionally, if an XML document is required for submission to ClinicalTrials.gov, ensure that you have provided sponsor, responsible party, and regulatory information.

--

How to Accept and Reject Trials

1. Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
2. On the Trial Identification page, check out the trial. For instructions, see Checking In and Checking Out Trials.
3. On the Validation menu, click Trial Validation. The Trial Validation page displays trial details.
   

4. To accept the trial, click Accept.

   Note
   Although you can accept a trial that requires an XML document for ClinicalTrials.gov without having provided Oversight Authority information, you may receive a warning if you do so.

   A message confirms acceptance, the trial processing status changes to Accepted, and the system sends a notification of acceptance email message to the trial submitter. Also, the abstraction menu appears with options specific to abstracting the trial.

   Section
   Column Abstraction Menu for Interventional Trials Column Abstraction Menu for Non-interventional Trials

5. To reject the trial, click Reject.
   The Reason For Rejection section appears. 

   Info
   When you reject a trial that is on-hold, the system takes the trial off hold.

   
   
   

6. In the Reason For Rejection field, type the reason for rejecting the trial. For example, if you rejected the trial because you found a duplicate record in the system, enter Duplicate of record NCI-2008-1234 .
7. Click Done.
   A message confirms rejection. The trial processing status changes to Rejected, and the system sends a notification of rejection email message to the trial submitter.