Safia Chambon

2007 - 2008 (One and a half year) : CRA regional Coordinator the inner/outer Paris suburbs: epidemiological and genomic Clinical search :Department Anaesthetises resuscitation Chirugicale,intensive care unit Paris :(SAR HEGP Pr Safran, SAR Ambroise Paré Pr Brasseur, SAR of the Centre René Huguenin Dr Jayr, SAR Louis Pr Jacob).
Assure that the regulation in force is operational otherwise to make myself the demands of license Afssaps, CPP and CNIL

1 To make sure that the regulation in force is operational otherwise to make myself the requests of license Afsapps, CPP and CNIL. Request the license to the director of hospitals and private sites. Ask the aptitude licence for the private centres."
Check CV signed, dated with Adeli number and number of the physician order.

2 Statutory Realization of documents (scientific letter, delegation of load(responsibility), assurance, during the opening idem for the closing of sites…)

3. Organize in total autonomy and the preparation of the slide presentation of the study,

4. Presentation of the study during the opening of every implied service of surgery and insure the feasibility of the study on sites and according to the GCP:
Taken of meeting and organization of the meeting with the doctors and their team care.
Supply and presentation of the documents of study (protocol, case report forms…).
Confirmation of the capacities of recruitment, and identification of the really implied investigators.
Establishment of a schedule of the periods of recruitment.
Sending of a report of visit of implementation in the national headquarter.
" Presentation of the logistic organization (circuit of delivery) of CRF for the preoperative balance).

5. Organize in total autonomy the implementation of the study in every implied service of surgery:
Taken of meeting and organization of the meeting with the doctors and team care,
Supply and presentation of the documents of study (protocol, care report form).
Presentation of the logistic organization (circuit of delivery blood sample of the patient case report form for the preoperative balance),
Confirmation of the capacities of recruitment, and identification of the really implied investigators,
Establishment of a schedule of the periods of recruitment,
Sending of a report of visit of implementation in the national coordinator.

6. Make regular visits of follow-up in every service of surgery. On the occasion of each of these visits, the rapport will have to make to national coordinator:
Discount of the inclusions, unconfirmed patients (patients to whom the inquiry was proposed but who refused to participate in it) and patients potentially incluables not included (patients to whom the inquiry was not proposed), the check of the completion, the collection of case report form).

7. Send to a national coordinator a weekly report balance of activity which will include:
The file of the inclusions,
The file of the not inclusions,
Reports of activity and monitoring on the progress of the study

8. Take in the questionnaires which must have returned by the 3-month-old patients and 6 months after the intervention and take care of the necessary reflations in case of no return of these questionnaires :
Before any step with the patient, acquaint with his general state with hisregular doctor or with the service of surgery in which was realized the intervention.
Phone call in the week which follows the sending to make sure of the good reception of the courier and propose a help to the completion or an explanation.
New courier if necessary.
Phone reminder one week later if no return of the questionnaire.

9. To organize, in contact with / Centres of Evaluation and Treatment of the Pain ( CETD) participating in the inquiry, the consultations of the patients which accept this follow-up:
Patient contact.
Contact CETD (organization to be seen according to the centres and the services).

10. Collect the additional information obtained during the consultati