[Good professional practices of French CICs - version # 2]. / Manuel de bonnes pratiques professionnelles des CIC ­ version no2.

French clinical investigation centers (CICs) are academic platforms dedicated to clinical research. The QUALI-CIC working group helps to improve and harmonize practices within the CIC network. After some years of implementation, the manual of good professional practices of CICs (MGPP CIC) completed in 2010, needed to be revised to best fit with the large panel of CIC activities. The aim was also to make it more accurate and to reinforce requirements about participants safety and data security. In its second version published in the present article, the MGPP CIC includes 255 items divided into 15 chapters. An explanatory document, currently being drafted, will complete the manual to facilitate its implementation.

Management of inflammatory bowel disease in France: a nationwide survey among private gastroenterologists.

BACKGROUND: Data on the current management of inflammatory bowel disease are scarce. METHODS: This was a nationwide survey among 65 private gastroenterologists treating patients with inflammatory bowel disease in France in 2012. RESULTS: A total of 375 inflammatory bowel disease patients were analysed: 48% had ulcerative colitis. One third of inflammatory bowel disease patients had a history of hospitalisation, and 40% of Crohn's disease patients had prior surgery. Two thirds of inflammatory bowel disease patients had active disease. Significantly fewer ulcerative colitis patients were treated with anti-tumour necrosis factor therapy than Crohn's disease patients (18.9% vs. 38.9%; p<0.0001). Among patients treated with anti-tumour necrosis factor, only 4.5% were receiving concomitant immunomodulators. Half of inflammatory bowel disease patients had undergone a colonoscopy within the past year. For colorectal cancer screening, random biopsies and chromoendoscopy were performed in 75% and 40% of cases, respectively. An endoscopic score was used for only 10% of inflammatory bowel disease patients. About one third of inflammatory bowel disease patients had imaging studies within the past year (magnetic resonance enterography in 65%). An abdominal computed tomography scan was prescribed for 12% of inflammatory bowel disease patients. CONCLUSIONS: Many patients still have active disease in the biologics era, and the number of patients receiving combination therapy is low in private practice. Chromoendoscopy and endoscopy scores are not often used.

[A manual of good professional practices for the Clinical Investigation Centres]. / Manuel de bonnes pratiques professionnelles des centres d'investigation clinique.

Clinical Investigation Centres (CICs) are academic organisations for performing clinical studies. They are a part of a national network which is co-ordinated by French national institute for health and medical research (Inserm), and the head office of healthcare provision (DGOS). There are working groups and specialised networks within the overall CIC network. The Harmonisation of CIC Procedures (HPCIC) group wrote a manual of good professional practices for clinical research. This manual is described here. This manual was written by consensus. It was approved by the coordinators of all CICs, external experts, and validated by representatives of both Inserm and the General directorate of healthcare provision (DGOS). The CIC Good Professional Practices manual is a guide divided into two sections. The first section covers the general management of a CIC (common to all CICs). The second section covers the core activities of CICs, running clinical studies (clinical study coordination, clinical investigation, data management, statistical analysis, valorisation). This manual is available for all CICs and any other clinical research organisations. It will serve as a basis for CIC self-quality evaluation, audits between CICs, and external audits. This manual shows how much the CICs want to standardise practices and procedures nationwide to offer their partners the best quality in performing clinical studies.

[Not Available]. / Manuel de bonnes pratiques professionnelles des centres d'investigation clinique.

Clinical Investigation Centres (CICs) are academic organisations for performing clinical studies. They are a part of a national network which is co-ordinated by French national institute for health and medical research (Inserm), and the head office of healthcare provision (DGOS). There are working groups and specialised networks within the overall CIC network. The Harmonisation of CIC Procedures (HPCIC) group wrote a manual of good professional practices for clinical research. This manual is described here. This manual was written by consensus. It was approved by the coordinators of all CICs, external experts, and validated by representatives of both Inserm and the General directorate of healthcare provision (DGOS). The CIC Good Professional Practices manual is a guide divided into two sections. The first section covers the general management of a CIC (common to all CICs). The second section covers the core activities of CICs, running clinical studies (clinical study coordination, clinical investigation, data management, statistical analysis, valorisation). This manual is available for all CICs and any other clinical research organisations. It will serve as a basis for CIC self-quality evaluation, audits between CICs, and external audits. This manual shows how much the CICs want to standardise practices and procedures nationwide to offer their partners the best quality in performing clinical studies.