3. Participant Information Sheet and Informed Consent Form, □ YES Master version. □ NO □ Not applicable 4. Participant Information Sheet and Informed Consent Form, □ YES site-specific version (both clean and tracked changes versions). □ NO □ Not applicable 5. Any information to be provided to study participants (e.g., □ YES participant identification cards, questionnaires, fact sheets): □ Master version(s); and NO WCHN-specific versions in clean and tracked □ changes version (if applicable) Not applicable 6. Any advertising materials. □ YES □ NO □ Not applicable 7. For investigational product (drug or therapeutic) trials, □ YES information about the investigational product, e.g., pharmacy manuals, investigator brochures, instructions for use.* □ NO □ Not applicable 8. Radiation safety or biosafety reports.* □ YES □ NO □ Not applicable These are only required in instances where WCHN HREC is not the lead HREC. Where WCHN HREC is the lead HREC, these documents are available on the WCHN HREC files and researchers need not provide them again with their SSA submission.
3. Participant Information Sheet and Informed Consent Form, Master version. □ YES □ NO □ Not applicable 4. Participant Information Sheet and Informed Consent Form, site-specific version (both clean and tracked changes versions). □ YES □ NO □ Not applicable 5. Any information to be provided to study participants (e.g., participant identification cards, questionnaires, fact sheets): Master version(s); and WCHN-specific versions in clean and tracked changes version (if applicable) □ YES □ NO □ Not applicable 6. Any advertising materials. □ YES □ NO □ Not applicable 7. For investigational product (drug or therapeutic) trials, information about the investigational product, e.g., pharmacy manuals, investigator brochures, instructions for use.* □ YES □ NO □ Not applicable 8. Radiation safety or biosafety reports.* □ YES □ NO □ Not applicable These are only required in instances where WCHN HREC is not the lead HREC. Where WCHN HREC is the lead HREC, these documents are available on the WCHN HREC files and researchers need not provide them again with their SSA submission.
WCHNSSAsubmissionguidelinesandchecklistsRevJuly2016.docx