When Protocol Design Involves:
Additional Training Required:
Evaluation of drugs, devices, biologics or interventional/behavioral
Good Clinical Practice (GCP)
treatments
National Science Foundation (NSF) funding
Responsible Conduct of Research (RCR)
Access and review of Protected Health Information (PHI)
Health Information Privacy & Security (HIPS)
Access and review of Protected Health Information (PHI)
Drexel Core Module HIPAA I
Access and review of Protected Health Information (PHI)
Drexel Core Module HIPAA II
Shipping biologic samples off DU campus
Infectious Substances Packaging
Enrollment of subjects unable to provide consent
Substituted (Surrogate) Consent
Use of recombinant materials,
manipulation/alteration/modification
Recombinant DNA Molecules Training
Use or processing of high risk controlled chemical/biologic agents Select Agent Policies and Procedures
Collection and analysis of biologic specimens in a “non” CAP/CLIA
Laboratory Safety and Bloodborne Pathogen Training
certified laboratory
Prisoners are engaged in the research protocol
CITI course: ID 506 Research with Prisoners in Social/Behavioral
protocols
OR
CITI course: ID 8 Research with Prisoners in Medical/biomedical
protocols
Examples:
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IRB Submission Log
Enrollment Log
Staff Signature Log and Delegation of Responsibility Log
Protocol specific training
Participant ID Log
Study Monitoring/Visit Log
Adverse Event Tracking Log
Participant Payment Form
Human Research Training Log
Other
• Refer to QA/QI website for samples under Study Management tools
http://www.drexel.edu/research/compliance/qa/
Karen Skinner, MSN, RN, NHA, CCRP
Drexel University
International Conference on Harmonization E6(R1). (1996). Guideline for good clinical practice ICH
harmonized tripartite guideline. Retrieved from
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy
/E6_R1/Step4/E6_R1__Guideline.pdf
U.S. Food and Drug Administration (2012) CFR- Code of Federal regulations Title 21. Retrieved
from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
U.S. Food and Drug Administration. (2013). CFR- Code of Federal regulations Title 45. Retrieved
from:
http://www.ecfr.gov/cgi-bin/textidx?c=ecfr&tpl=/ecfrbrowse/Title45/45cfr46_main_02.tpl