I am co-author of a clinical research memento, come help us!
Over a year ago, I told you about a book I loved. A book to put in all hands whether you are experienced or a beginner CRA, Project Manager or CRA Manager. Laurence Culine and her co-authors are preparing to update the 3rd version of this gem!
The team, in alphabetical order:
- Camille BERNEUR-MORISSEAU, Data Manager in clinical research, West Cancer Institute
- Laurence Culine, Head Clinical Research Group, Elsan Group (Paris)
- Marie CASTERA-Tellier, Pharmacist, Director of CPC-NOC, Centre François Baclesse (Caen)
- Emmanuelle MATHIEU, Project Engineer / Tenders, Directorate of Research and Innovation – CHU Montpellier
Little surprise: This year, I joined the team of co-authors to participate in the drafting of the 3rd edition!
We need your expert advice of CRA junior, senior, of data manager, in charge of vigilance, project manager and manager! Come help us to make this memento even more complete and participate in the competition.
This book now has a clear and condensed description of the following topics related to clinical research:
- Reference texts (and must!) apply to biomedical research,
- The Structures related to biomedical research (CIOMS, WHO, CPP, ministry …)
- The Pharmacovigilance (mode of operation in France)
- The Authorities involved in biomedical research
- The Specificities of biomedical research in the hospital setting (e.g. DIRC, DRCI, DGOS, funding research / project calls …)
- The Methodology in biomedical research
- The actors of biomedical research promoter side and investigator site side (The promoter, the investigator, the investigator coordinator, the CSC, the CRA, the biostatistician / methodologist, the pharmacist, the data Manager, the vigilance and the patient in charge)
- an overview of the practicality of clinical trials for the selection of centers at the end of the promoter side
- an overview of the practicality of clinical trials of the investigator side
- information concerning quality assurance in clinical trials
The book is currently focused on clinical trials for human medicines.