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Study Record Instructions
If YES to Human Subjects
PHS Human Subjects and Clinical Trials Information Form (HSCT form) - open with Adobe Reader only
Delayed Onset studies have a specific definition and instructions.
If the study is not a Delayed Onset study, add a Human Subject Study Record for each proposed study.
The Human Subject Study Record Attachment is extracted from the HSCT form and is used to collect human subjects study data.
- On the HSCT form, respond “Yes” to the question “Are Human Subjects Involved?”
- Respond to the question “Is the Project Exempt from Federal Regulations?”
- Responding to these questions should activate the gray bar in the middle of the HSCT form, “Click here to extract the Human Subject Study Record Attachment”.
- Click and save the file to your desktop or another location for retrieval. The file will be called HumanSubjectStudy-V1.0.pdf
- Complete a Human Subject Study Record for each study as a PDF file, and each PDF file must have a unique file name. Troubleshooting tips
- The Human Subject Study Record file(s) are then attached to the HSCT form under the Study Records section. Attach Study Record number 1.
- Click the Add New Study button on the HSCT form to create more lines if there are additional study records.