CSR Development - Part I

Exit Survey

1) Who approves OTM trial RAP M3 and M7 modules in CREDI?

Lead Statistician, Medical Lead, Study Lead

Lead Statistician, Lead Programmer, Medical Lead, MW

Lead Statistician, Medical Lead, MW, Study Lead

Lead Statistician, Lead Programmer, Medical Lead

2) Who approves Oncology CP trial RAP M3&M7 modules in CREDI?

Lead CP Programmer

MW, Medical Lead

Global Head of CP (or delegate), Global Head of Biostatistics CP (or delegate)

All the above

3) Who approves OCD&GMA trial RAP M3&M7 modules in CREDI?

Lead Statistician, Medical Lead, Study Lead

Lead Statistician, Lead Programmer, Medical Lead, MW

Lead Statistician, Medical Lead, MW, Study Lead

Lead Statistician, Lead Programmer, Medical Lead

4) Who approves OGD&GMA trial Dry-run in CREDI?

Study Lead 2 and MW

Study Lead 2, Lead programmer and MW

Study Lead 2, Lead programmer, Lead Statistician and MW

Lead Statistician and MW

5) Please select the correct order of PK data flow in clinical trials?

Clinical data base lock=>Bio-analytical data are complete (all samples analyzed and reconciled against clinical database) =>Declare Bio-analytical data lock=>PK merge of bio-analytical and clinical data=>Declare PK Lock

Bio-analytical data are complete (all samples analyzed and reconciled against clinical database) =>Declare Bio-analytical data lock=>Clinical data base lock=>PK merge of bio-analytical and clinical data=> Declare PK Lock

Bio-analytical data are complete (all samples analyzed and reconciled against clinical database) => Declare Bio-analytical data lock=>PK merge of bio-analytical and clinical data=>Clinical data base lock=> Declare PK Lock

6) What is the process if the clinical trial team would like to use non-standard Tables, Listings and Figures (not part of by Oncology Standard Outputs) in RAP M7 for their study?

Statistician and MW to take approval from their Line function

Statistician to submit request to OSO for approval

Study lead to submit request to OSO for approval

All the above

7) Clinical trial analysis plan (RAP M3) and lay out of CSR TLFs (RAP M7) should be completed and approved in CREDI by

M3: FPFV+1 Months, M7: FPFV+4 Months

M3: FPFV+2 Months, M7: FPFV+5 Months

M3: FPFV+3 Months, M7: FPFV+6 Months

M3: FPFV+4 Months, M7: FPFV+7 Months

8) What are the standard timelines for availability of all planned clinical TLFs (table, listing, and figure) in CREDI?

CDBL + 10 WDs

CDBL + 15 WDs

CDBL + 20 WDs

CDBL + 25 WDs

9) What are the standard timelines for availability of all planned PK TLFs (table, listing, and figure) in CREDI?

PK Lock + 5 WDs

PK Lock + 10 WDs

PK Lock + 15 WDs

PK Lock + 20 WDs

10) What is the location of the Clinical Study Report Quality Content Checklist in CREDI?

Administrative files (study level)

CSR Report folder

Pub CSR folder

Appendix 16.1.8