1. Conduct site initiation visit (for industry sponsored trials only) and study start-up meetings with pharmacy, CTRU, clinic, Infusion Treatment Area (ITA) and others as appropriate. If you are using the ITA, submit the Research Study Quick Reference form and submit it as instructed in the form.
2. OnCore will notify investigators by email once all the proper signoffs and approvals are in place and the study is ready to be opened to accrual. The PI or study coordinator must provide the actual date the study is opened to accrual. Once you have opened the study to accrual, email this date to CCTO-OnCore@stanford.edu. It is important to Stanford’s SRC and as well as for reporting purposes to the NCI that the open to accrual date be accurate.
3. Participant recruitment
4. Participant enrollment
5. Report adverse events (AE) and deviations
Reporting to SCI. Report all SAEs CTCAE Grade 3 and above to ccto-safety@stanford.edu for institutional record keeping. Investigators should send completed CRFs and follow up reports only; do not send lab reports or copies of medical records. Use Stanford secure email and indicate the OnCore or eProtocol number in the subject line. Report protocol deviations into OnCore.
Reporting FDA. For all Sponsor-investigator IND studies, submit all SAE events to the IND within the specified timeframes.
SOP: Documenting and Reporting Protocol Deviations
Reporting to Stanford IRB. Report Unanticipated Problems Involving Risks to Participants or Others (UPs) directly to the Stanford IRB using the “Report” option in eProtocol. Refer to IRB policy guidance Events and Information that Require Prompt Reporting to the IRB for further information and additional guidance.
6. DSMC
- The Data and Safety Monitoring Committee (DSMC) ensures the safety of participants in all cancer clinical trials by reviewing grade 3 and above adverse events and protocol deviations. It is also responsible for auditing for protocol compliance, data validity and integrity of institutionally sponsored, investigator authored treatment trials.
- For Stanford Investigator-initiated treatment studies, the DSMC coordinator will notify you when your study is to be audited. Protocols are audited minimally on an annual basis. Get more information on DSMC operations plan here.
- For preparation assistance for an upcoming DSMC review request CCTO assistance.
- For Investigators contacted by an industry sponsor in regard to an upcoming monitoring session email ccto-admin@stanford.edu to gain access to a monitoring conference room.
7. FDA audit