INTERNAL MEDICINE PULSE PAGE - All SOPs and supporting documents are filed by topic here
The Clinical Trials Unit provides a set of Standard Operating Procedures (SOPs) to guide the conduct of clinical research in the department. All clinical trials whose PI has a primary appointment in the Dept. of Internal Medicine must follow these SOPs for study procedures.
The SOPs cover a variety of topics in the following categories:
- Clinical Trial Operations (e.g., Consent, Record Keeping, Internal Auditing)
- Finance (e.g., Industry Trial Costs)
- Regulatory (e.g., FDA Inspections)
Many of the SOPs are also accompanied by supporting Work Practice Documents (describing how specific procedures should be performed) and example forms.
Investigator-Initiated Trials Guidance Documents and Forms
In addition to the SOPs, a set of guidance documents has been developed to outline the process and requirements for the start up of Investigator-Initiated Trials. We encourage all investigators and clinical research coordinators to reference these forms when planning a new study. These documents are filed under the Investigator Initiated Trial Start-up Process heading on the Pulse page.