The implementation of the VICH GL9 on Good Clinical Practice in July 2001 has raised much interest amongst professionals such as, monitors, clinical investigators, veterinary surgeons and auditors. Its objective is to provide guidance on the design and conduct of all clinical studies of veterinary products.
This workshop plenary session intends to identify the requirements stated in this VICH GL, and the major changes with the current CVMP GL. The issue being really broad and complex, the workshop will also hold three breakout sessions in which SOPs, training, and study documentation will be discussed in more depth.
Workshop breakout session 1: Standard Operating Procedures.
Chair: M. Pott
Consistency in the conduct of clinical trials and transparency between all parties involved, sponsor, monitor and investigator, rely on Standard Operating Procedures (SOPs). If well designed and implemented, these play a key role in the quality and success of a study. The aim of this session is to identify and define essential SOPs required during all steps of a clinical trial, in order to perform high quality trials.
Aim of the breakout session:
1) Identify SOPs
2) Define SOPs
3) Proposal for updating process
4) Reflection on the availability to all parties
Some examples of organisational SOPs:
Workshop breakout session 2: Training.
Chair: N. Tawiah.
As stated in the VICH GL9, “Each individual involved in conducting a clinical study should be qualified by education, training, and expertise to perform their respective task(s).” The VICH GL9 also refers to “scientific training” for the Investigators and Monitors.
Aim of the breakout session: to identify how sponsors can ensure optimal training of individuals involved in conducting clinical studies to VICH GL9.
Discussions:
1) Who should be trained?
2) When and at what frequency?
3) What should be the content of training?
4) Ways of training:
- Who should be the trainer?
- What training materials should be used (e.g. CD-ROMs)?
- What form should the training take (on the job, external)?
- To what extent should we train each individual?
5) How do we document the training?
Workshop breakout session 3: Study Documentation.
Chair: Jill Ashley-Smith.
Study documentation consists of those records that individually and collectively permit evaluation of the conduct of the study and the quality of the data produced. It includes information generated throughout a trial from the study protocol, to the final study report. As a study generates large quantities of data, these must be accurately entered and validated; the care given to the collection and maintenance of the study documentation will also contribute to the success of the different assessment phases of the trial.
Aim of the breakout session:
1) Data entry: is direct capture the optimal way?
2) Management of the large quantities of data:
- Data required to reconstruct a study – Study Master File.
- Collection of multicentre studies data
- Archiving data
3) Data traceability and validation
4) Trial / data amendments
5) Use of e-CRFs: raw data / final report
6) How to deal with foreign language data
