 |
Page History
...
| Column | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| |||||||||||
|
...
This page tree describes the process of validating clinical trial data that have been submitted to the Clinical Trials Reporting Program (CTRP). It also provides instructions for accepting and rejecting clinical trials based on your review.
Main Steps for Validating Submitted Trial
...
| MultiExcerptName | validatetrial |
|---|
...
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
- Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
- On the Trial Identification page, check out the trial. For instructions, see Checking In and Checking Out Trials.
- Optionally, on the Trial Overview menu, click View TSR to view and print the Trial Summary Report.
- 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.
- Modify the trial details as necessary.
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 .
- On the Validation menu, click Trial Validation.
- Accept or reject the trial by following the instructions in Accepting and Rejecting Trials.
Selecting Trials that Require Validation
...
| MultiExcerptName | selecttrial |
|---|
...
Submitted trials that are ready for validation are listed in search results tables along with trials in other stages of the processing life cycle (Processing Status). You can list only those trials that require validation by limiting your search to trials that have the processing status, Submitted. Or, you can sort an existing list of trials by the Action column.
How to Search for Trials that Require Validation
- Follow the instructions in Searching for Trials, using only the Processing Status criterion, Submitted.
- Select one of the following trial categories from the Search by Trial Category drop-down list on the Trial Search page:
- To limit your search to Complete trials, select Complete.
-or- - To limit your trial search to Abbreviated trials, select Abbreviated.
Trials that require validation are listed in the search results table.
- To limit your search to Complete trials, select Complete.
In the Action column for the trial you want to validate, click Validate. Or, click the NCI Trial Identifier link.
The Trial Identification page appears with information about the selected trial. The Validation menu appears with different options depending on whether the trial is Complete or Abbreviated.Section Column Validation Menu for Complete Trials
Column Validation Menu for Abbreviated Trials
How to Sort Search Results by Validation Status
...
Validating Documents
...
| MultiExcerptName | reviewdocs |
|---|
...
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
...
| Note | ||
|---|---|---|
| ||
You must submit a participating sites document for a multi-site trial if the participating sites data are not included in the protocol document. |
...
- 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.
...
Validating Trial Status
...
| MultiExcerptName | reviewstatus |
|---|
...
| Info | ||
|---|---|---|
| ||
| Trial Status validation does not pertain to Abbreviated trials. |
Ensure that the relationships between statuses and dates follow the rules provided in the tables and diagrams that follow.
...
If you transition from this status...
...
To this status...
...
The system creates this status
...
In Review
...
Active, or Enrolling by Invitation
...
Approved
...
Active, or Enrolling by Invitation
...
Closed to Accrual and Intervention
...
Closed to Accrual
...
Active, or Enrolling by Invitation
...
Completed
...
- Closed to Accrual
- Closed to Accrual and Intervention
...
Temporarily Closed to Accrual
...
Administratively Completed
...
Temporarily Closed to Accrual and Intervention
...
Temporarily Closed to Accrual
...
Closed to Accrual
...
None
...
Temporarily Closed to Accrual
...
Closed to Accrual and Intervention
...
None
...
Temporarily Closed to Accrual and Intervention
...
Closed to Accrual
...
None
...
Temporarily Closed to Accrual and Intervention
...
Closed to Accrual and Intervention
...
None
...
How to Review Trial Status Details
...
On the Validation menu, click Trial Status. The Trial Status page appears.
...
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*
...
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 | ||
|---|---|---|
| ||
Primary Completion Dates are optional in the following cases:
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
...
Validating Funding
...
| MultiExcerptName | reviewfunding |
|---|
...
| Info | ||
|---|---|---|
| ||
Funding validation does not pertain to Abbreviated trials. |
How to Validate Funding Details
- Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
- On the Trial Identification page, check out the trial. For instructions, see Checking In and Checking Out Trials.
- On the Validation menu, click Trial Funding.
The Trial Funding page appears and may display one or more funding records.
- 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.
- If the submitter determines that one of the records is a duplicate, delete the duplicate by following instructions in the next step.
- 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.
- If you made any changes, click Save.
...
| icon | false |
|---|
...
| Page Tree | ||||
|---|---|---|---|---|
|
Validating Trial INDs and IDEs
...
| MultiExcerptName | reviewind |
|---|
...
| Info | ||
|---|---|---|
| ||
IND/IDE validation does not pertain to Abbreviated trials. |
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
...
- 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.
...
Validating Trial Identification Details
...
| MultiExcerptName | trialdetails |
|---|
...
How to Validate Trial Details
...
On the Validation menu, click Trial Validation.
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*
...
...
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.
...
- 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.
Validating Regulatory Information
...
| MultiExcerptName | reviewregulatory |
|---|
...
| Info | ||
|---|---|---|
| ||
Regulatory information validation does not pertain to Abbreviated trials. |
These instructions pertain to complete trials that require XML documents for submission to ClinicalTrials.gov.
How to Validate Regulatory Information
...
Validating Participating Sites
...
| MultiExcerptName | reviewparticipatingsites |
|---|
...
| Info | ||
|---|---|---|
| ||
Participating sites validation does not pertain to Complete trials. |
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
- Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
- On the Trial Identification page, check out the trial. For instructions, see Checking In and Checking Out Trials.
- On the Validation menu, click Participating Sites.
The Participating Sites Page appears.
- 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.
- If you made any changes, click Save.
Validating Amended Trials
...
| MultiExcerptName | reviewamendment |
|---|
...
| Info | ||
|---|---|---|
| ||
| Amended trial validation does not pertain to Abbreviated trials. |
...
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.
...
| title | Rejecting Amended Trial Submissions |
|---|
...
How to Change an Amendment Reason Code
...
Accepting and Rejecting Trials
...
| MultiExcerptName | acceptreject |
|---|
...
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.
| Note |
|---|
If you determine that a trial is an invalid submission, search for valid submissions in the CTRP database. |
Before you accept a trial, verify the following trial characteristics:
Distinctiveness.
Verify that the trial is not a duplicate of one previously registered and accepted in the CTRP.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.
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.
--
| Footnotes Display |
|---|
How to Accept and Reject Trials
...
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 | ||||
|---|---|---|---|---|
|
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. |
...
| title | Rejecting Amended Trial Submissions |
|---|
...
