Question

complex cutoff instruction

Records Management

Updated July 24, 2015

asked on July 24, 2015

I’m trying to determine the best way to create a particular cutoff instruction. The cutoff instruction has two branches. The two branches deal with whether the protocol in question was completed or terminated.

If the protocol was completed there are two events, a 'Complete Date' and an 'FDAAA/IRB Complete date'. Both a Complete Date and an FDAAA/IRB Complete Date are required with a cutoff date of 5 years after the FDAAA/IRB date.

If the protocol is terminated there are 3 options ‘OEWG Terminated’, ‘Disapproved’ or ‘Withdrawn’. If any of these events happen the cutoff is 1 year rather than 5 years.

Is there is any way to create a cutoff instruction with an alternate instruction similar to what is available for a retention schedule or do we have to set up two separate cutoff instructions and switch the cutoff instruction to the terminated instruction if the protocol is terminated?

I was hoping to be able to tie the 2 cutoff instructions together somehow so the user would not have to hunt for the alternate cutoff instruction.

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replied on July 24, 2015

There isn't a way to create conditional cutoff instructions like that, although I appreciate the use case.

Is the Complete Date used in determining eligibility? It sounds like it's just the FDAAA/IRB complete date that it's relevant here for the success case, since it's 5 years from that date? Also if Terminated, disapproved, or withdrawn occur, is the 1 year retention than based on the date of that termination, disapproved, or withdrawn, or are those in addition to the initial complete date.

Basically, I'm curious if there's a way we could represent this using alt. retention instead of having to switch cutoff instructions.

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replied on July 24, 2015

I'm not really sure why but both dates are required even though the FDAAA/IRB date is the terminating event for completion. The Termination events are separate from the Completion dates, neither Completion Date will occur if the protocol is terminated. The 1 year is a cutoff interval, not a 1 year retention. The Retention Schedule is the same if the protocol is completed or terminated.

That's why I was hoping to be able to indicate an 'alternate' cutoff instruction. I know we can change the cutoff instruction if the protocol is terminated but was just hoping for something a little more elegant.

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complex cutoff instruction

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