Kandrea Collins, RN, BA, MA, Senior Clinical Team Manager Suzanne Olsen, RN, CCRC, Senior Clinical Research Associate

Transcription

1 Kandrea Collins, RN, BA, MA, Senior Clinical Team Manager Suzanne Olsen, RN, CCRC, Senior Clinical Research Associate

2 Who is PPD? Pharmaceutical Product Development Contract Research Organization (CRO) 2nd largest in the world

3 Who is PPD? Clinical Site Monitoring Group has held contract with DAIDS since Includes: Monitoring QA Training Laboratory services

4 Who is PPD? The CSMG team: Clinical Research Associates Also, Project Assistants Management Other Personnel

5 CRA training Contractual requirements Clinical Foundation CSMG Training

6 PPD Orientation Clinical Foundation Training Required for all new clinical staff (managers/monitors) Two full weeks General GCP/ICH and PPD specific hands on exercises mandatory passing of post-assessment

7 PPD Orientation CSMG / Protocol Training At least one week in-house includes: DAIDS overview Network-specific orientation OHRP on-line (Human Subjects Protection) Record Review Tools Report completion DAIDS Standard Operating Procedures Project Specific Work Instructions

8 PPD Orientation Additionally, At least 3 training trips Co-Monitoring trips Annual group training Monthly staff meetings

9 Monitoring Visits Clinical Site Monitoring Group

10 Why do we need them??? When do they occur????? Who does them??? Where do they take place????

11 Who conducts the monitoring visit? Clinical Research Associates who have completed all required training assessments and received authorization for monitoring. 2

12 Why are monitoring visits necessary? Assess adherence to Federal Regulations and ICH guidelines Assess adherence to the Protocol Determine that the rights and safety of human subjects have been properly protected Provide education to investigational staff

13 When do monitoring visits occur? The visit schedule is determined by the sponsor. Typically they occur quarterly. Can be adjusted by sponsor request / approval.

14 Where do monitoring visits take place? Where records are maintained, participants are seen and/or drug is stored Main Units Affiliated Units

15 Preparing for the visit DAIDS assignment Scheduling the Visit 4 full days (~32 hours) Domestic versus International Visa requirements / Special permits Travel warnings Translators

16 Travel arrangements to and from site Pre-Visit Letter 10 to 15 days prior to visit Dates of visit Items required by monitor / protocols to be reviewed Assessments to be completed Suggested debriefing time Monitor s contact information

17 Gather materials for visit Protocol books Assessment documents (Shells) PID list Blank Record Review Tools Necessary office supplies

18 PID lists Generated by computer Randomized Unannounced

19 Conducting the visit Sign the monitoring log daily Review subject records Source documentation Case Report Forms Laboratory Reports Completion of SAE forms Informed Consent / Eligibility

20 Additional assessments Pharmacy Site Operations Regulatory Follow up from previous reports Special assignments Education: Source Documentation Good Clinical Practice

21 Review of Findings RRT Part B s Other assessments (regulatory, etc.) Documents left at site Original signed PID list Copies of Part B s

22 Debriefing Purpose to inform the site of findings / teach At end of visit Attendees Principal Investigator Study Coordinator Pharmacists Study Staff

23 NO SURPRISES! At end of monitoring visit, site personnel should be fully aware of any problems noted during the visit.

24 After the visit RRT submission Entering information into data base Writing the report Report Review Process Report Distribution Everyone gets report at same time

25 Report content Site Monitoring Report Record Review Summary Pharmacy Reports Site Specific Protocol Specific Inventory Other Reports

26 Monitoring Visits should be a collaborative experience