Site Activation: Keep Your Eyes on the Prize

Site Activation: Keep Your Eyes on the Prize Theresa Gamble, Ph.D. Senior Clinical Research Manager HPTN CORE, FHI October 2004 Slide 1

The Prize Site-Specific Protocol Activation Notice See Example Document 1 Slide 2

Components of the Notice The following site has met all Protocol Registration and Study Activation requirements and is hereby approved to begin screening and enrollment in the study entitled: WITHOUT THE NOTICE, YOU CANNOT BEGIN THE STUDY!!! Slide 3

Current Federal Wide Assurance (FWA) For Each Relevant IRB/EC TIP 1) We check the OHRP website (http://www.hhs.gov/ohrp/) TIP 2) So should you Slide 4

Completion of US FDA 30-day Review Period TIP 1) This only applies to IND studies TIP 2) If you are an HPTN site, there is nothing for you to do (this is usually handled by DAIDS) Slide 5

Local Regulatory Authority Approval of the Study Protocol (other than IRB approval) TIP 1) Only the site knows if this is required TIP 2) Keep the HPTN CORE informed of the status and timeline TIP 3) The HPTN CORE or DAIDS can often help provide necessary documents or information TIP 4) Provide the HPTN CORE with documentation of approval in English Slide 6

Examples Local Regulatory Authority Approval of the Study Protocol Drug Controller General of India (DCGI) Health Ministry s Screening Committee (HMSC) Thai FDA Slide 7

Completion of Human Subjects Research Training for All Key Staff TIP 1) Key staff is defined by NIH as anyone who designs or conducts the study TIP 2) At a minimum, train all staff who interact with study participants TIP 3) Have a plan to train new staff Slide 8

Examples Completion of Human Subjects Research Training for All Key Staff www.hptn.org Annual HPTN Meeting At U.S. Institutions A copy of the attendance sheet or copies of the certificates are acceptable documentation Slide 9

Completion of Good Clinical Practice (GCP) Training by at Least One Study Staff Member with Responsibility for Oversight of Study Implementation TIP 1) Strongly recommend that as many staff as possible receive this training TIP 2) If only one or two staff can be trained, choose the Investigator of Record, the Investigator who signs the 1572, or the study coordinator TIP 3) Have a plan to train new staff Slide 10

Examples Completion of Good Clinical Practice (GCP) Training by at Least One Study Staff Member with Responsibility for Oversight of Study Implementation On Site PPD Training Annual HPTN Meeting Online Courses At U.S. Institutions or Companies A copy of the attendance sheet or copies of the certificates are acceptable documentation Slide 11

Protocol Registration Approval from the DAIDS RCC Protocol Registration Office based on: Approvals from all responsible IRBs/ECs IRB/EC-approved informed consent forms (local language and back-translation) Original Signed FDA Form 1572 or Investigator of Record Agreement CV of the Investigator of Record or 1572 Signee Slide 12

Slide 13 Protocol Registration Approval from the DAIDS RCC Protocol Registration Office TIP 1) Make sure your approval letters are in English and have the components required by the DAIDS Protocol Registration Manual TIP 2) Stay close to the ICF template, clearly label your consent forms, submit documentation of approval TIP 3) Check the 1572 or IoR for accuracy TIP 4) Have the IoR sign and date the CV

Examples IRB Approval Letter DAIDS-Required Elements Complete Protocol Title DAIDS Protocol Number DAIDS Protocol Version Number Date of IRB/EC Approval See Example Document 2 Slide 14

Examples IRB Approval Letter This is an excellent example of documenting that all consent forms have been approved. See Example Document 3 Slide 15

Examples IRB Approval Letter DAIDS-Required Elements IRB/EC Chairperson or Member Designee Signature IRB/EC Representative s Title Slide 16 See Example Document 4

Examples Protocol Registration Approval from DAIDS/RCC Protocol Registration Office Slide 17 See Example Document 5

DAIDS-Approved Pharmacy Establishment Plan (PEP) and Pharmacy SOP TIP 1) DAIDS PAB provides feedback and approval for these documents TIP 2) Provide HPTN CORE with documentation of approval TIP 3) Give yourself time there is usually some back and forth with DAIDS PAB Slide 18

All Applicable Import and Export Approvals for Study Products TIP 1) Only the site knows if these are required TIP 2) Keep the HPTN CORE informed of the status and timeline TIP 3) The HPTN CORE or DAIDS can often help provide necessary documents or information TIP 4) Provide the HPTN CORE with documentation of approval in English Slide 19

All Applicable Import and Export Approvals for Study Products TIP 5) Many parties are usually involved in this process - bureaucracy is the same all over - give yourself enough time!!! Slide 20

Study Staff Signature Sheet, Roster, and Delegation of Duties TIP 1) The easiest way to do this is a single log TIP 2) Your procedure should show when staff join and leave the project and if their duties change Slide 21

Examples Study Staff Signature Sheet, Roster, and Delegation of Duties NAME SIGNATURE INITIALS CREDENTIALS STUDY RESPONS- IBILITIES IoR DESIGNEE (Y/N) IF YES IoR INITIALS START DATE END DATE T. Gamble TRG Ph.D. B, C, G Y GD 01/01/04 01/30/04 M. McCauley MM MPH B, C, G Y GD 02/01/04 T. Gamble TRG Ph.D. D N 02/15/04 A, Investigator of Record B, Subinvestigator C, Verifies Eligibility D, Ships Specimens E, Study Coordinator F, Lab Technician G, Consents Participants H, Research Clinician I, Performs Study Assessments Slide 22

SCHARP Approval of Site Readiness for Data Management TIP 1) SCHARP Protocol Operations Coordinator (POC) guides preparedness activities and provides approval TIP 2) Stay in touch with your POC Slide 23

HPTN CL Approval of Local Laboratory Readiness TIP 1) HPTN Central Lab guides preparedness activities and provides approval TIP 2) The lab validation process takes time plan accordingly Slide 24

Required SOPs, Accrual and Retention Plans, and HIV Counseling Procedures TIP 1) Find out exactly what is required for your study TIP 2) Submit drafts early TIP 3) Agree on the process of review and approval TIP 4) Version 1.0 will change, don t agonize Slide 25

Examples SOP Review and Approval Process Set out expectations and timelines Designate point person for changes Use tracked changes appropriately Maintain version control SOPs can really help in the long run. Slide 26

PPD Study-Specific Initiation Visits TIP 1) Respond to the report in a timely fashion TIP 2) Proactively follow-up on issues Slide 27

Completion of Study-Specific Training and Resolution of Issues that are Identified during Training TIP 1) Use the training to walk-through your SOPs Slide 28 TIP 2) Clarify what issues are rate-limiting for site activation

Examples Resolution of issues that are identified during training REQUIRED FOR SITE ACTIVATION New IoR Agreement Site is missing CVs or financial disclosure forms Site has concerns about keeping drug within required temperature range The type of syphilis confirmatory test to be used for study was undetermined NOT REQUIRED FOR SITE ACTIVATION Approval of version 3.1 of ICFs when version 3.0 is available Finalize procedure to re-label medication that is nearing expiration Site will review ICFs and ICF process with CAB Site needs to hire an additional Medical Officer Slide 29

General Advice TIP 1) Determine a process of communication TIP 2) Track your progress TIP 3) Be organized TIP 4) Remember, we re all going to the same place, enjoy the ride Slide 30

Keep Your Eyes on the Prize Slide 31