At any given time during the course of the trial validation and abstraction processes, trial discrepancies (for example, missing required documents, inconsistencies in trial information, etc.) may arise that require further clarification from the Administrative Team Lead or trial submitter. In such cases, put the trial on hold.
The following steps are required before placing or releasing a trial on hold during validation:
- Provide a specific description, and include your initials.
Example:
Correct: Trial does not have a protocol document; contacted trial submitter/RM.
Incorrect: Clarification on protocol document/RM. - For internal questions related to workflow procedures, ask the Administrative Team Lead for guidance. Otherwise, email the trial submitter immediately to resolve discrepancies. Do not accept the trial until the problem is resolved.
- When the issue is resolved with the Administrative Team Lead or the trial submitter, take the trial off hold.
Review and track all incomplete submissions and trials with discrepancies often to ensure the trials are processed accordingly.
The system sends an on-hold notice to the submitter and trial record owners as soon as you put the trial on hold for the following reasons: a) Submission Incomplete, and b) Submission Incomplete - Missing Documents. It then sends on-hold reminder email messages to the submitter and trial record owners automatically every three (3) business days.
If no response is received within one week, send a follow-up reminder via email.
If no response is received within one week after the second email, call the trial submitter.
If no resolution or response is available, take the trial off hold.
How to Place a Trial Record On Hold
Search for the trial of interest. For instructions, refer to Searching for Trials in PA.
In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)
- On the main menu, click On-hold Information. The On-hold Information page appears.
- Click Add. The Add On-hold Record page appears.
- In the On-hold Reason Code drop-down list, select the code that indicates the reason that the trial abstraction is delayed.
The following table defines the reason codes for the on-hold status:Code Definition Submission Incomplete (Submitter) Required information has been requested Submission Incomplete - Missing Documents (Submitter) The following errors are associated with the Submission Incomplete code: - Wrong protocol document or IRB approval
- Outdated IRB approval
- Missing Informed Consent
- Missing/incomplete Participating Sites document
Invalid Grant (Submitter) Grant validation failure. The system generates a message to the submitter when this occurs. Pending CTRP Review (CTRP) CTRP review has been requested Pending Disease Curation (CTRP) Disease curation has been requested Pending Person Curation (CTRP) Person curation has been requested Pending Organization Curation (CTRP) Organization curation has been requested Pending Intervention Curation (CTRP) Intervention curation has been requested Other (Submitter) Any other reason not listed above, where processing of the trial is waiting for the submitter Other (CTRP) Any other reason not listed above, where processing of the trial is waiting for CTRP - If you selected Other as the reason code, you can also specify a reason category. In the Reason Category field, specify whether a response is needed from the submitter or from CTRP.
In the On-hold Description field, type an explanation for putting the trial on hold. You can enter up to 200 characters. A running character count is displayed as you type.
The date on which you place the record on hold is entered automatically in the On-hold Date field.
Click Save.
The system takes a trial off hold if it is rejected at the validation stage.
