Standard Operating Procedures (SOPs)

 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.