December 4, 2018

Meeting Presentation

Welcome to the December 4th CTRP User Call! The topics covered in the 12-04-2018 Presentation are as follows:

Please submit any future CTRP user call agenda topics to the CTRO (NCICTRO@mail.nih.gov).
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Abbreviated Accrual (e.g., Industrial Trials) Batch Load Overwriting

There was an email that was sent out [to the listserv] about batch submitting accruals and potential for overwriting previous accrual submissions (if manually submitted)- can you elaborate?
- Accrual batch file submissions should contain cumulative accrual data. We look for all the accrual data on the trial to be submitted with each batch accrual submission. With each new batch file submitted, the previous accrual data in CTRP will be overwritten.
If you manually entered cumulative accrual through the GUI on a study then later on submitted another cumulative accrual on the same study, does it wipe out the previous historical submission? E.g. if I submitted 10 in 2017 (manual) then 15 in 2018, does mixing methods wipe out the manual submission?
- Yes, if you update the data in the GUI, you cannot append the data via a batch file submission. The batch file will overwrite all previously submitted accrual data. You must submit cumulative data via the batch file submission mechanism.
Following up on mixed method submission - What I'm getting at is when I generated a sample DT4s for 2017 and 2018, the totals became incorrect for 2017, following a batch upload of accruals for 2018.

This likely has to do with the batch file upload overwriting the previously submitted accrual data sequence, and the use of the cut-off date for the summary accrual reporting.

Patient Level Batch Loading

But the batch file for subject level data is NOT cumulative, right?
- Correct.

Abstraction Status

Can you see status for abstractions of amendments or just initial registrations?
- Yes, you can see the processing status of the trial (for initial registrations and amendments). The trial submission process status must be in the “Verification Response” or “Verification, No Response” trial processing status.

Overall Trial Information

Can you describe the process of verifying the trial type and primary purpose once a new trial is submitted into the CTRP system? What is the process for QA'ing the coding of trials in CTRP? I've run across trials that are coded as a treatment trial that I wouldn't interpret as treatment per CCSG guidelines. I've also seen trials coded as national or external peer reviewed, that locally I would have coded differently. My reason for asking is that we have tried to code our trials in our clinical trials management system the same way it is coded in CTRP and when I run my local DT4, I run into discrepancies when comparing to the CTRP DT4.
- The Trial Type and Purpose is provided upon submission from the lead organization. The CTRO reviews this data for accuracy during their abstraction process, but we rely on the trial submitter for these elements. If there are any disagreements, please feel free to reach out to the CTRO to confirm the intent of the trial and/or provide TSR feedback in a timely fashion.

Data Table 4 Generation

With centers now generating their own dt4 interventional; must that be generated from STRAP?
- Yes, the center should be submitting their own CTRP-generated DT4 report, using the STRAP tool/application.
If the overall status of abbreviated trial is closed to accrual, we are unable to see the trials in DT4 even if they are open at the center.
- Correct, the overall trial and at least one participating site from the Cancer Center must be open to accrual during the reporting period display on a CTRP-generated DT4 report.

Umbrella Trials

Has there been any re-thinking re: Umbrella studies?
- General accrual reporting: MATCH is one trial record in CTRP and all accrual is reported to the screening trial; there is no distinction between the screening vs treatment accruals at this point. For subsequent umbrella studies, NCI has taken the approach to have a screening protocol and distinct treatment protocols.
Does this mean we report all accruals for MATCH in CTRP, regardless of whether they are screening or treatment accruals?
- MATCH is an NCI managed study. The NCI submits accrual to CTRP on your center’s behalf. When there are accrual data discrepancies, please contact the CTRO (NCICTRO@mail.nih.gov) for assistance in resolving the accrual data discrepancies.