Clinical Research Support
Quality Assurance Office for Clinical Trials (QACT)
FAQ - Frequently Asked Questions
How do you register a subject to a protocol with the QACT?
Before administering protocol treatment, fax (617-632-2295) the eligibility checklist and a complete copy of the consent form to the QACT Protocol Registrar to enroll and/or randomize the subject (tel. 617-632-3761, page 41049). When registrations must take place during off-hours and holidays, call the QACT registration line (617-632-3761) and leave a message on line 1 with detailed registration information and a return phone number. The registrar on-call will be paged. Fax the completed eligibility checklist and consent form to the QACT (617-632-2295) before treatment begins.
For more detailed information please refer to the Registration Information.
What type of reports can be generated by the QACT?
- Patient Accrual & Race/Ethnicity and Gender Reports: Contact a QACT Registrar (617-632-3761) with your request. Please be sure to include a secure fax number to which this confidential information may be sent.
- Missing Forms Report: Contact Data Analyst or QACT Data Management Manager (617-632-2505)
- Data Requests (Toxicity lists, etc.): Complete Data Request Form and submit to QACT Data Management Manager
- Protocol Analysis: Submit Data Request Form to QACT Data Management Manager and contact Biostatistician
Whom should I contact to create Case Report Forms (CRFs) for DF/HCC PI-initiated studies?
Contact the QACT Data Analyst assigned to the protocol or contact the Assistant Director of QACT.
What is the process for submitting paper CRFs to the QACT?
Completed original copies of the CRFs are submitted to the QACT according to the instructions on each CRF. Data Managers / CRCs should keep copies of all submitted paperwork in their research records.
- Paper CRFs are completed according to the instructions on each CRF, and submitted in one of three ways:
1. Scanned and emailed to the QACT Data Analyst
2. Sent via Interoffice Mail to the QACT Data Analyst
3. Faxed to the QACT Data Analyst at 617-632-2295
- Data Managers / CRCs should keep copies of all submitted paperwork in their research records.
What is the process for data query generation and resolution for paper CRFs?
- Data queries for paper CRFs are e-mailed to the Data Manager/CRC by the Data Analyst and the Data Manager/CRC replies by e-mail, resubmitting amended paper forms as appropriate.
Why do we need a DSMB or a DSMC at DF/HCC?
First, all the different oversight groups that we have do not perform the same functions as the Data and Safety Monitoring Board (DSMB) or the Data and Safety Monitoring Committee (DSMC).
1. The Dana-Farber Cancer Institute's Cancer Institutional Review Board (IRB) reviews (IRB responsible for DF/HCC protocols):
- Protocol and study documentation
- Evaluates the trial with respect to whether risk to subjects is minimized and if the trial is acceptable at this site
- Reviews ongoing safety at the site(s)
- Does not generally review unblinded data
- May take action based on the DSMB and DSMC recommendations to the Principal Investigator (PI)
2. Clinical Investigations Leadership Committee (CLC):
- Reviews policies and systems issues related to clinical research
- Reviews audit reports to identify system-wide issues with study conduct
- Make recommendations based on the DSMB and DSMC deliberations to the Principal Investigator (PI)
3. The Internal Audit Program:
- Reviews protocols for compliance
- Limited in the sense that usually the problems identified do not include all patients in the study (only 5-6 patients are selected for a given audit)
4. The DF/HCC DSMBs (meaning DSMB and DSMC):
- Review the entire information available for all enrolled patients
- Review mortality or major morbidity as endpoint to ensure safety, efficacy, and trial integrity
- Heightened awareness within the scientific community of problems in clinical trial conduct and analysis that might lead to inaccurate or biased results, especially when early termination is possible
- Ensure that all problems identified by the DSMB or DSMC are addressed appropriately