Good Clinical Practice (GCP) & Regulatory Program
To submit a request for clinical research compliance services, please complete the services request form.
The goal of the CTO’s clinical research compliance program is to promote operational excellence, best practices, and regulatory compliance in clinical research conducted at Dartmouth.The services offered by the clinical research compliance program include:
- On-site monitoring for GCP compliance
During an on-site monitoring visit, staff review regulatory documentation and reviews subject files, including consent forms. All on-site monitoring visits include an exit interview and a written report, both of which address all on-site observations, corrective actions, and quality improvement recommendations. Written reports are distributed to the Principal Investigator (PI) for purposes of quality improvement and education.
- Preparation for external audits
The CTO’s clinical research compliance staff has the knowledge, expertise, and experience to assist study sites as they prepare for upcoming audits by the FDA, NIH, sponsors, or other external agencies. Upon receipt of an audit notification, study staff may request an on-site review of all study files.This internal pre-audit provides the PI/study site the opportunity to identify deficiencies and take necessary corrective actions before an external audit commences.
- Investigational New Drug (IND)/Investigational Device Exemption (IDE) Consultation
Clinical research compliance staff can guide investigators in the IND/IDE application process and train investigators and study teams about the FDA regulatory requirements associated with holding an IND/IDE. Read more
- GCP toolkit
To assist investigators with study documentation, the clinical research compliance staff can provide study sites with logs, templates, and compliance checklists. In addition, annotated study binders can be provided to research sites to aid in regulatory compliance.
- Consultation and education
Small group in-service: This service provides the study site with an opportunity to ask questions, discuss policies and address site-specific issues relating to the conduct of GCP-compliant clinical research
Consultation for study start-up: Clinical research compliance can assist investigators with "study start-up." Using the IRB-approved protocol and working with the research team, the CTO staff can develop study-specific data collection forms to allow for the capture, access, and management of study data. In addition, CTO staff members can offer assistance with study coordination, including proper recordkeeping and study documentation.
- Assistance with study registration on Clinicaltrials.gov
- Find a Clinical Trial
- New Study Start Up
- Contracting Office
- Managing a Study
- Protocol Amendments
- Closing a Study
- Investigational Pharmacy
- Education & Training
- Clinical Research Compliance Program
- Regulatory Information
- Research Links
- Frequently Asked Questions
- Contact Information