Other terms
- Colon cancer
- Companion Diagnostics CDx
- Concomitant Medication
- Conflict of Interest
- Congestive Heart Failure (CHF)
- Conjunctivitis
- Control Group
- Controlled Clinical Trial
- Corneal Abrasion/Ulcer
- Coronary Artery Disease (CAD)
- CRA (Clinical Research Associates)
- CRO (Contract Research Organization)
ClinOps (Clinical Operations)
Clinical Operations refer to the activities that support the clinical trial process from start-up to close out. Clinical Operation professionals are tasked with the planning, implementation, management, and execution of the clinical trial process.
Clinical Operations involve a broad range of activities to ensure timely execution and adherence to human subject regulations and policies of Good Clinical Practice:
- Development of protocol and other study documents.
- Identification of clinical trial sites and investigators.
- Training, startup, and management of clinical sites.
- Managing logistics of study materials.
- Providing a channel of communication between research teams specializing in clinical science, statistics, pharmacovigilance, data science, regulatory activities, legal, and marketing, while keeping them up to date and on task.
- Fiscal management.
- Identifying project risks and planning for changes ahead of time.
- Internal and external stakeholder management.
- Quality management.
- Trial closeout and reporting.
Clinical operation roles include Clinical Operations Directors, Project Managers, Clinical Trial Managers, Clinical Research Associates/ Trial Monitors, and Clinical Trial Assistants.
Read more about ClinOps on our blog: Defining ClinOps in Trials
Learn more about the Vial Contract Research Organization (CRO)
Source: Cramer, G. (2020, March 10). Assessing the Operational Complexity of a Clinical Trial: The Experience of the National Institute of Mental Health. ACRP. Retrieved January 25, 2022, from https://acrpnet.org/2020/03/10/assessing-the-operational-complexity-of-a-clinical-trial-the-experience-of-the-national-institute-of-mental-health/
