Conducting ETCTN Research
Once an ETCTN study is active at DF/HCC, the investigators and study team must conduct the study in accordance with both ETCTN and DF/HCC policies and procedures. When a DF/HCC investigator is the national study chair s/he has additional responsibilities such as amending the protocol document, the informed consent and keeping the CIRB informed of study progress. Follow the menu items below that are most appropriate for your study.
DF/HCC Investigator is the National Study Chair | DF/HCC is a Participating Site | |
| Participant Enrollment | Yes | Yes |
| Data Management | Yes | Yes |
| Continuing Reviews Guide | Yes | Yes |
| Continuing Reviews to CTEP Workflow | Yes | N/A |
| Chair-Initiated Amendment Requests to CTEP Guide | Yes | N/A |
| CTEP-Initiated Amendments: Requests for Amendments (RAs) and Rapid Requests for Amendments (RRAs) Guide | Yes | N/A |
| Amendments to CTEP Workflow | Yes | N/A |
| Amendments to OHRS Guide | Yes | Yes |
| Amendments to OHRS Workflow | Yes | Yes |
| Adverse Event Reporting Guide | Yes | Yes |
| Adverse Event Reporting Workflow | Yes | Yes |
| Drug Safety Notifications | Yes | Yes |
| eDTL Guide | Yes | Yes |
| NCI CIRB Change of PI Worksheet Guide | Yes | Yes |
| ETCTN Study Closure for DF/HCC Participating Sites | Yes | Yes |