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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.

Tip

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.

Info

A single trial can have one or more On-hold records at any time

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Info
titleCheck out the trial before you begin abstraction

Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data.

Putting Trial Records On Hold

trialonhold

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.
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.
    On-hold Information page displaying one recordImage Removed
    Click Add. The Add On-hold Record page appears.
    On-hold Information - Add On-hold Record pageImage Removed
    In the On-hold Reason Code drop-down list, select the code that indicates the reason that the trial abstraction is delayed.
  • 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.

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    titleReview and track all incomplete submissions and trials with discrepancies often to ensure the trials are processed accordingly.
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    Info

    The date on which you place the record on hold is entered automatically in the On-hold Date field.

  • Click Save.

    Info

    The system takes a trial off hold if it is rejected at the validation stage.

    • Return to top of page

    Taking Trial Records Off Hold

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    MultiExcerptNametrialoffhold

    You can edit a trial that is currently on hold when the submitter/owner has provided missing information, or when there is no response from the submitter/owner, by entering an off-hold date. You can not make any other changes to the record.

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    How to Edit an On-hold Record

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    Search for the trial of interest (a trial that is currently on hold). For instructions, refer to Searching for Trials in PA.

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    In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

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    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.)

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    For instructions, refer to the following pages:

    Page Tree
    rootPutting Trial Processing On Hold

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    Return to top of page