On hold records contain information about a delay in trial processing that includes the cause of the delay, the date the delay started, and the date that the trial was taken off hold.
You can continue to abstract a trial while it is on hold. However, you can not record any milestones.
You can add and edit On-hold records at any time during the validation and abstraction processes. However, the only data in an On-hold record that you can edit is the Off-hold date. That is, you can take a delayed trial off hold by editing an existing On-hold record.
A single trial can have one or more On-hold records at any time.
Putting Trial Records 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. For information, refer to On Hold Reason Codes.
- 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.
Taking Trial Records Off Hold
How to Edit an On-hold Record
Search for the trial of interest (a trial that is currently on hold). 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.)
- In the main menu, click On-hold Information. The On-hold Information page appears.
- Click the Edit icon. The Edit On-hold Record page appears.
On-hold Information Page – Edit On-hold Record - If you have sufficient information to continue the abstraction, select the date on which you resume abstraction in Off-hold Date field. This date must be in the past or the current date.
- Click Save.