Clinical Research Support

Quality Assurance Office for Clinical Trials (QACT)

FAQ

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 Assistant Director
Data Requests (Toxicity lists, etc.): Complete Data Request Form and submit to QACT Assistant Director
Protocol Analysis: Submit Data Request Form to QACT Assistant Director 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 the QACT.

What is the process for submitting data or queries 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.

Submit CRFs to QACT Data Analyst
Data queries will be e-mailed to the CRA by the Data Analyst and the CRA should reply by e-mail

Why do we need a DSMB or a DSMC at Dana-Farber/Harvard Cancer Center?
First, all the different oversight groups that we have do not perform the same functions as the Data and Safety Monitoring Board (DSMB) and/or the Data & Safety Monitoring Committee (DSMC).

1. The Dana-Farber Cancer Institutional Review Board (IRB) reviews:

Protocol and study documentation
Evaluates the trial with respect to - whether risk to subjects are 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. The Clinical Investigations & Oversight Policy Committee (CLINPOC):

Reviews policies and systems issues related to clinical research
Reviews audit reports and manages corrective actions as needed
May take action based on the DSMB and DSMC recommendations 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 and/or bias results, especially when an early termination is a possibility
Ensure that all identified problems by the DSMB or DSMC are addressed appropriately
Support stopping for futility; that is, when the likelihood that the treatment effect being sought based on the interim data, is very unlikely to be established
Monitor treatment group comparisons of outcome data (interim analysis):

Safety
Efficacy

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Clinical Research Support Quality Assurance Office for Clinical Trials (QACT) FAQ FAQ - Frequently Asked Questions How do you register a subject to a protocol with the QACT? What type of reports can be generated by the QACT? Whom should I contact to create Case Report Forms (CRFs) for DF/HCC PI-Initiated studies? What is the process for submitting data or queries to the QACT? Why do we need a DSMB or a DSMC at Dana-Farber/Harvard Cancer Center? 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 Assistant Director Data Requests (Toxicity lists, etc.): Complete Data Request Form and submit to QACT Assistant Director Protocol Analysis: Submit Data Request Form to QACT Assistant Director 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 the QACT. What is the process for submitting data or queries 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. Submit CRFs to QACT Data Analyst Data queries will be e-mailed to the CRA by the Data Analyst and the CRA should reply by e-mail Why do we need a DSMB or a DSMC at Dana-Farber/Harvard Cancer Center? First, all the different oversight groups that we have do not perform the same functions as the Data and Safety Monitoring Board (DSMB) and/or the Data & Safety Monitoring Committee (DSMC). 1. The Dana-Farber Cancer Institutional Review Board (IRB) reviews: Protocol and study documentation Evaluates the trial with respect to - whether risk to subjects are 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. The Clinical Investigations & Oversight Policy Committee (CLINPOC): Reviews policies and systems issues related to clinical research Reviews audit reports and manages corrective actions as needed May take action based on the DSMB and DSMC recommendations 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 and/or bias results, especially when an early termination is a possibility Ensure that all identified problems by the DSMB or DSMC are addressed appropriately Support stopping for futility; that is, when the likelihood that the treatment effect being sought based on the interim data, is very unlikely to be established Monitor treatment group comparisons of outcome data (interim analysis): Safety Efficacy	Office for Human Research Studies (OHRS) Quality Assurance Office for Clinical Trials (QACT) Forms, Policies, and Manuals CLINPOC Multi-Center Trials Contacts Clinical Research List-serv FAQ Clinical Research Unit (CRU) Clinical Trials Education Office (CTEO) Protocol Review and Monitoring System (PRMS)
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