The word “review” can describe several activities. For a useful sponsor or CRO discussion, clarify the purpose, reviewers and access boundaries first.
Three different purposes
| Activity | Main purpose | Who performs it |
|---|---|---|
| Monitoring | Oversight of trial progress and conduct | Specialists appointed by the sponsor under a monitoring plan |
| Audit | Independent examination of selected processes and records | Auditors independent of the activity being audited |
| Inspection | An official regulatory review | An authorised regulatory authority |
This short explanation follows ICH E6(R3), section 3.11 and the glossary. It uses an international reference; determine the applicable procedure for the jurisdiction and study concerned.
What to agree before a visit
A practical discussion list, rather than a description of reviews carried out at Bessalar:
- Purpose and scope: site selection, a particular protocol or a specific process?
- Records: which list, period and document versions are needed?
- People: who demonstrates the process, answers questions and records agreements?
- Access and confidentiality: where can records be reviewed, and how is unnecessary disclosure of personal information avoided?
- Follow-up: how will findings be presented, and who discusses responses and subsequent actions?
Do not send source medical records through the general website form. Agree document access separately.
Reading a review history
Instead of a row of logos, request information that may be disclosed: review type, date, scope and supporting evidence. A review having taken place and specific findings having been closed are different facts. Historical evidence does not establish that processes remain unchanged today.
Publishing another organisation’s name or logo also requires a separate check of the basis for doing so. This article does not announce clinic partners, audit outcomes or inspection results.
Next step
Read about the quality system and site selection questions. In an enquiry to the clinic, describe the purpose of the proposed visit and document scope. Agree arrangements before sharing materials.
Reference checked on 24 October 2026. Independently written educational material, not an audit opinion, legal advice or a statement of ICH endorsement.
Questions and answers
Does a sponsor audit replace a regulatory inspection?
No. Audits and regulatory inspections differ in authority, purpose and personnel. An audit alone does not authorise a new study or establish that a site can deliver every protocol.
Does an audit establish a partnership?
No. A separate basis and permission to disclose the relationship are needed. Naming an auditor or the organisation commissioning a review is not, by itself, a recommendation of the clinic.
See also
Quality management system
Participant safety and data reliability are ensured by a quality management system: standard operating procedures, internal and external audits and regular staff training.
Learn more
How to evaluate a clinical study site: questions for sponsors and CROs
Before choosing a site, ask the clinic for documents or data on twelve points — from the right to operate and experience to the quality system, the cold chain, safety, recruitment, data handling and ethics review.
Learn more
How we work: project stages from enquiry to report
A project starts with a synopsis or protocol. We assess feasibility, prepare a proposal, take part in the documents and ethics review, recruit volunteers, run the study under the protocol and transfer samples and data. At every stage it is clear what we do and what is needed from the sponsor or CRO.
Learn more