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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.

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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.

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

Putting Trial Records On Hold

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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.

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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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Putting Trial Records On Hold

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Putting Trial Records On Hold

How to Place a Trial Record On Hold

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Search for the trial of interest. 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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- Include v4.4
Putting Trial Records On Hold

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- Include v4.4

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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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Click Save.

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

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Taking Trial Records Off Hold

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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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Taking Trial Records Off Hold - Include v4.4
Taking Trial Records Off Hold - Include v4.4

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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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