Below are 3 Investigator Self-Assessment forms, please choose the one(s) most appropriate for you.
Use these checklists to assist in maintaining and organizing study documentation and assisting in maintaining compliance. Further instructions are located at the top of each Self-Assessment form.
If you have questions while filling out the Investigator Self-Assessment, or would like the Quality Improvement Program (QIP) team to complete the assessment for you, please contact us at qip@hsph.harvard.edu.
Regulatory Documentation: Complete the Regulatory Documentation Self-Assessment to confirm documentation maintained in your regulatory files.
Participant Files: Complete the Participant File Self-Assessment if you have direct access to participant files. If you do not have direct access to participant files, (e.g., they are not stored locally and/or easily accessible virtually), you may skip completing the Participant File Self-Assessment. Alternatively, you may choose to have a member of a remote study team complete this section of the Self-Assessment for the participant files available at their site.
Investigational Drug/Device: Complete the Investigational Drug/Device Self-Assessment only if your study involves an investigational drug and/or device under an IND/IDE. Answer all questions as they pertain to the study conduct and the study documentation maintained in your regulatory files.
(Note: The Investigational Drug/Device Self-Assessment includes a Regulatory Documentation section and should be used in place of the stand-alone Regulatory Documentation Self-Assessment form.)
