Investigator | Overview
Training is a crucial component of conducting clinical research. The investigator and all study personnel involved in the design and/or conduct of research involving human subjects are required to receive adequate training. Investigators need to have processes in place for training their study staff on individual protocols and amendments to meet the expectations of the Food and Drug Administration (FDA), additional regulatory bodies and sponsors.
Education resources
| Statistical design and analysis of research studies | Investigators interested in education about the statistical design and analysis of research studies, including survey and qualitative methods, can visit the Biostatistics and Research Design Center. |
| Harvard Catalyst education and training in clinical and translational research | Harvard Catalyst offers numerous online and in-person courses, as well as training programs, ranging from short programs, providing an overview of clinical/translational research, to multi-year, advanced programs for senior fellows and faculty members. |
| Clinical Research Virtual Mentor | Email the Clinical Research Virtual Mentor for real-time answers to clinical research questions. Questions are answered in one day or less. |
| Clinical research education opportunities | View the calendar of upcoming clinical research education opportunities (VPN). |
| Required training for first-time principal investigators of interventional trials | All first-time principal investigators of interventional trials (drugs, biologics or devices) will be required to complete training prior to release of their study by the IRB. As part of the IRB review process, any first-time principal investigator of an interventional trial will be notified that specific training needs to be completed. Training details are located in the policy document. For any questions, contact Erica Denhoff, ICCTR Clinical Research Education Program Manager. |
| Required training for first-time IND and IDE holders | All first-time IND and IDE holders will be required to complete training prior to release of their study by the Institutional Review Board (IRB). As part of the IRB review process, any first-time IND or IDE holder will be notified that specific training needs to be completed. Please note that physicians who have only held expanded access INDs for the treatment of an individual patient, under 21 CFR 312.310, are still considered to be first-time IND holders when holding an IND for a clinical trial. Training details are located in the policy document. For any questions, contact Erica Denhoff, ICCTR Clinical Research Education Program Manager. |
