Standards for the conduct of research, particularly clinical studies and trials, have never been higher or more complex. From meeting institutional, state, and federal funding guidelines to ensuring uniformity in the execution of routine functions in a department or office, clear processes and procedures have likewise become critically important.
The CCTS SOP Library offers nearly two dozen templates for establishing standard operating procedures (SOPs), easily tailored to fit your clinical operating, regulatory, and fiscal management needs. Help your research team perform at its best while also ensuring your research meets risk-based monitoring rules with our SOPs.
Below we list several templates currently available. This list is not exhaustive, and we plan to add several more in the near future, so bookmark this page as a helpful resource. Do you have an idea for an SOP or wish to request a template you don’t see? Contact our
CLINICAL/OPERATING (CL)
- Adverse Event and Serious Adverse Event Reporting
- PI Oversight
- Data Management: CRF Completion and Query Resolution
REGULATORY/MANAGEMENT (RM) INCLUDES DEVICE STUDIES
- Regulatory Document Management Process (Initial and Continuous Submissions)
- Sponsor, CRO and Internal Audits
- Site Specific Informed Consent Form
- Closing a Study
- FDA Audits Drug Accountability
FISCAL MANAGEMENT (FM)
- Reviewing the Protocol for Financial Impact
- Conflict of Interest (COI) Reporting
- Monthly Reporting and Reconciliation