Q & A Assessment of Nicotine Dose #2.docx

QUESTIONS AND ANSWERS ASSESSMENT OF NICOTINE DOSE DISCRIMINATION IN MARKETED CIGARETTES #2

The term Study Monitor, or CTP Study Monitor, is used to describe the CTP personnel who will conduct remote monitoring requests during recruitment. The Contractor should have their own site monitoring plan in place, so the goal of the CTP Study Monitor is to simply provide additional oversight of the data and human subject protection monitoring, ensuring all a site monitoring system is in place, the quality of the monitoring activity is appropriate, and that the site is prepared should an FDA Audit occur.

Question 04: Task 5 Data Monitoring: please clarify what CRA/Monitoring vs. Safety/Monitoring will be performed as per the SOW. For example, Part 4.7 mentions the ‘FDA personnel or a vendor on behalf of FDA may conduct site visits’. We presume this to mean that another entity (not the awarded contractor) would be doing some form of CRA/Site Monitoring – please confirm.

Answer 04:

a. The primary goal of CTP study monitoring is to ensure adherence to the study protocol and informed consent procedures as well as compliance with:

i. Federal and State regulations governing research

ii. Standard Operating Procedures of the FDA IRB and

iii. Good Clinical Practice (GCP) guidelines.

b. The CTP Study Monitor will conduct study monitoring requests at approximately 25%, 75% and 100% of recruitment to ensure that we are audit ready. The requested materials will include:

i. IRB-approved protocol and amendments

ii. IRB approval letters

iii. Protocol Deviations

iv. Informed Consent Form and other materials provided to the participants, including recruitment materials and resources

v. Screening and Enrollment Logs

vi. Case report forms and any other source documents

vii. Medical histories, physical exams

viii. Delegation Log(s), including clearly outlined roles and responsibilities

ix. Logs for study test articles, supplies, and equipment (where applicable)

x. Investigational product accountability log(s), including product storage, dispensing and disposition information (if applicable)

xi. Investigator’s study files, including all regulatory documents and electronic records

xii. Adverse experiences/ unanticipated events reporting and tracking procedures and reports

xiii. Randomization logs/blinding data

c. Part 4.7 of the RTOP speaks to the ability for the FDA-CTP Quality Assurance and Quality Improvement team to audit this study at any point until the contract is complete. This formal audit could occur at any point during participant recruitment or once recruitment is complete. The office who performs study audits, the Office of Compliance and Enforcement, resides in a different part of the Center and works independently with their own contractors to perform random audits of CTP funded research.

Question 05:

Task 6: the RFP notes that multiple review rounds (“iterations”) are expected, with no limit on the times or timelines. Please confirm/clarify whether there would be similar limits for Task 6, as those noted for Task 5 (e.g., “maximum 4 rounds of edits”).