Quality Control (QC)
The main tasks are to check that the documentation and records collected during clinical development comply with all applicable GCP (Good Clinical Practice) and SOP (Standard Operating Procedures) standards, and that they are appropriately stored. There is a wide variety of other tasks, ranging from reviewing and adjusting QC procedures in consultation with the clinical trial sponsor, creating and revising SOPs, and reviewing case data. QC officers engage in the whole spectrum of quality control activities and are responsible for checking that the quality of clinical trials is assured from an objective, third-party perspective.
Work tasks and work flow
QC officers can get involved in multiple projects, dealing with everything from the start to end of clinical trials.
(1) Creating SOPs relating to QC
(2) Checking of work related to requests, contracts, and completion procedures for clinical trials
(3) Checking of work related to collection, evaluation, and communication of safety information
(4) Checking of work related to clinical trial drug management
(5) Checking of work related to handling of case report forms and other clinical trial data
(6) Checking monitoring reports
(7) Checking the content of clinical study reports
(8) Storing records related to the above work
Characteristics of Linical QC
Linical’s QC officers do not merely check quality against a check list — they get actively involved in projects, giving advice in accordance with the applicable GCP, SOP, and protocols of each project. For this reason, Linical’s QC officers participate in the same seminars as monitors and strive to acquire a wide-ranging, up-to-date body of medical and pharmaceutical knowledge. By participating in project meetings, resolving issues through discussions with monitors, and providing guidance to less experienced monitors, QC officers make a significant contribution to the ultimate goal of getting new drugs approved.
The skills listed below can be mastered through work experience and training.
- Communication: Giving appropriate advice and guidance to monitors, sharing information with clients and within the team/section
- Regulations: Meeting regulatory requirements, understanding and applying ICH-GCP/Risk Based Approach
- Negotiation: Proposing QC inspection methods, creating and proposing various SOPs and manuals, and suggesting solutions to issues
- Presentation: Implementing training and study groups, conveying information to specific projects