Sep 7, 2016 - Questions 8: Will a diary be used by the subjects on the study? ... Questions 13: We note that Project Man
WITS REPRODUCTIVE HEALTH & HIV INSTITUTE Request for proposal (RFP) for Clinical Trial Services QUESTION AND ANSWER Questions 1: Can we assume Regulatory and Ethics activities have been completed? Answer: Yes. Questions 2: Could you please confirm the expected screening failure rate? Answer: ±15%. Questions 3: Will the CRO be required to collect Screening Failure data in the database and do source verification of these Screening Failures? Answer: Yes. Questions 4: Please confirm the number of Interim analyses. Answer: Two (2). Questions 5: Please confirm the number of planned DSMB meetings. Answer: Two (2). Questions 6: Will the CRO be responsible for the set up and running of the DSMB team? Answer: No, but the CRO will assist with providing data and preparing the DSMB presentation slides. Questions 7: SAEs: the RFP states 120 SAEs with 50 expedited SAEs: Can we assume the expedited SAEs refers to SUSARS? Is the total # of SAEs then 170 SAEs or does the 50 form part of the 120 SAEs in total? 200 SAE narratives requested‐ please clarify numbers as this differs to number of SAEs expected Answer: Assuming a total of 150 ‐ 200 SAEs (expected + unexpected). 200 S/AE narratives as some AEs may be included if they lead to a significant events like study discontinuation. Questions 8: Will a diary be used by the subjects on the study? Answer: No. Questions 9: Will CRO SOPs be used for the study? Answer: Only for CRO task areas. Questions 10: Please clarify if full Medical Monitoring services are required in addition to pharmacovigilance services listed. Answer: CRO's medical officer will review SAEs and provide recommendations where necessary. Questions 11: Can we assume electronic transfer of laboratory data into the database? Answer: Yes, where possible. Questions 12: Do all sites have experience working with EDC? Answer: Yes. Questions 13: We note that Project Management has not been requested but due to this being a full service opportunity we will ideally require oversight by central contact person in CRO. Please confirm this is acceptable. Page 1 of 2
Answer: No.
Questions 14: Appendix 2: Service specifications Task List ‐ Draft analysis of AE / SAE for reporting: in reference to AE, does this refer to AEs of medical importance? Answer: Yes. Questions 15: Appendix 3: Assumptions: CRO Site Initiation Visits: Is the number of SIVs = 1 for each site or will there be a combination Investigator Meeting/Site Training/SIV for all 3 sites together? Answer: One (1) SIV with all 3 sites combined. Questions 16: Does WHRI have a tracking system or will CRO use internal system? Answer: WitsRHI has internal tracking systems. Questions 17: Since the South African government now provides access to HIV treatment for patients with HIV infection with a specified CD4 cell count range, do you expect it to be challenging to find treatment naïve subjects? May we enrol subjects with any CD4 cell count, given that this is now becoming standard of care in North America and Europe? Answer: In this study there are no cd4 count threshold criteria. Questions 18: We understand that the current study timeline dates may change. In our experience the varied activities related to study start‐up generally require more time than the WitsRHI timeline suggests. Please confirm the first patient enrolment date is so soon after contract award. Answer: First patient enrol date could be within 2‐4 weeks following contract award. Please note that there will be discussions with the CRO around timelines in the final agreement. Questions 19: Can you please confirm that you expect the vendor to provide 24/7 emergency medical contact (medical monitoring coverage)? Answer: Each site has their own 24/7 emergency medical contact for participants Questions 20: Could you please clarify what is meant by task “SAE form completion” (Appendix 2 of the RFP document)? Would you like to approve SAE report prepared (processed) by CRO or do you refer to SAE form (paper form) preparation or is it something completely different? Answer: SAE reporting process: each site completes sae paper form, sends to Pharmacovigilance (by email), Pharmacovigilance notifies site of receipt, reviews, comments and sends queries (where necessary), captures into safety database, and tracks the sae to resolution. Questions 21: Can you please confirm that you have performed a feasibility to assume that 1100 subjects can be recruited in 60 days from those 3 sites? We reckon you do have close relationships with those sites, however we’d like to understand how you made those assumptions. Answer: The 60 days period is the screening window within which a participant must be screened and enrolled into the study. Accrual period will be around 10 months. All sites have experience in accruing large number of participants from previous studies. Enrolling participants will not be CRO's task, good to understand this. The study teams have been tasked with screening and enrolling participants into the study. CRO will be involved only in the 4 tasks as stated and specified in the task list in the tender document.
