When a study file is ready to send
A file is ready when four things are true. If one is missing, the file stops. It is not “mostly ready.” The person who prepares the file is not the only person who checks it.
The work this form came from
250+studies through setup and handoff
150+files prepared or checked
50+procedures staff could finish alone
Ready means all four
- The consent matches the procedures named in the submission.
- The review-board packet matches the system record, including the study identifiers.
- Conflict-of-interest filings are present for the people on the study.
- Billing setup matches the enrollment path.
The second reader
A second reader marks each item pass or return, with the line that failed. The file does not go forward on a verbal “it looked fine.”
| Item | Pass or return | Line that failed |
|---|---|---|
| Consent matches procedures | ||
| Packet matches the system record | ||
| Conflict-of-interest filings | ||
| Billing matches enrollment |
The point of the procedure was that the next coordinator could finish it without a ticket. Active use of the electronic systems rose from about 20 people to about 150. Repeat support fell about 80 percent. I did not manage the investigators. The procedure and the training did the adoption work.