eNERGY Protocole signe V2.0 2017.11.06.pdf


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ENERGY

Trial Code Sponsor 35RC16_9734 / GFPC 08-2015 / BMS CA209-449

7.3.2 Method of relationship assessment ...................................................................................................... 49
7.3.3 Declaration of unexpected serious adverse events .............................................................................. 50
7.3.4 Transmission of annual safety reports ................................................................................................. 50
7.3.5 Declaration of other safety data .......................................................................................................... 50
7.4 Expected adverse reactions specific to the present study ........................................................................... 50
7.4.1 Adverse reactions related to Nivolumab or Ipilimumab ...................................................................... 50
7.4.2 Adverse reactions related to Carboplatin ............................................................................................ 55
7.4.3 Adverse reactions related to Pemetrexed ............................................................................................ 56
7.4.4 Adverse reactions related to Paclitaxel ............................................................................................... 56
8
STATISTICAL METHODS AND SAMPLE SIZE DETERMINATION........................................... 56
Sample size consideration ................................................................................................................................. 56
Definition of population .................................................................................................................................... 57
Endpoints .......................................................................................................................................................... 57
9
RIGHT OF ACCESS TO DATA AND SOURCE DOCUMENTS ...................................................... 58
9.1. Access to data ............................................................................................................................................ 58
9.2. Source documents ...................................................................................................................................... 58
9.3. Confidentiality of data ............................................................................................................................... 58
10 QUALITY CONTROL AND ASSURANCE.......................................................................................... 59
11 ETHICAL CONSIDERATIONS............................................................................................................. 59
11.1. Regulatory and institutional review ......................................................................................................... 59
11.2. Substantial changes .................................................................................................................................. 59
11.3. Information for patients and written informed consent form................................................................... 59
12 DATA PROCESSING AND RETENTION OF DOCUMENTS AND DATA .................................... 59
12.1. Case report forms and data entry ............................................................................................................. 59
12.2. CNIL ........................................................................................................................................................ 60
12.3. Archiving ................................................................................................................................................. 60
13 INSURANCE ............................................................................................................................................. 60
14 STUDY FEASIBILITY ............................................................................................................................ 60
15 RULES PERTAINING TO PUBLICATION ......................................................................................... 60
16 LIST OF APPENDIX ............................................................................................................................... 60

Protocole

Version 2.0 du 06/11/2017

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