1. 1 ICSSC International Clinical Sciences Support Center Family Health International

2. What is the ICSSC? DMID contract for investigators funded by NIH/NIAID/DMID conducting research at resource-constrained foreign sites DMID contract for investigators funded by NIH/NIAID/DMID conducting research at resource-constrained foreign sites Located at Family Health International (FHI), a diverse public health research organization working mainly in the developing world. Located at Family Health International (FHI), a diverse public health research organization working mainly in the developing world. Composed of an interdisciplinary team of experts in various areas of clinical research. Composed of an interdisciplinary team of experts in various areas of clinical research.

3. Who is the ICSSC? Clinical Trials/ Protocol Specialists Data ManagersBiostatisticians Study Design/ Methodology Experts Logistics/ Event Planners Who is the ICSSC?

4. ICSSC Services Protocol Development Protocol Development Site Assessment Site Assessment Data Management Data Management Biostatistics Biostatistics Training Training Etc. Etc.

5. Where is the ICSSC?

6. Requesting Assistance New ICIDR….need HELP? New ICIDR….need HELP? Contact your DMID Program OfficerContact your DMID Program Officer Contact the International Clinical Sciences Support Center (ICSSC) http://www.icssc.org/Contact the International Clinical Sciences Support Center (ICSSC) http://www.icssc.org/

7. Study Protocol ICH GCP 1.44: “A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial.”

8. ICSSC Protocol Development Services (1) Protocol Pre-Review Protocol Pre-Review ClarityClarity CompletenessCompleteness GCP complianceGCP compliance Proper use of DMID protocol templates http://www.niaid.nih.gov/dmid/clinresearchProper use of DMID protocol templates http://www.niaid.nih.gov/dmid/clinresearch http://www.niaid.nih.gov/dmid/clinresearch DMID Study Product Template DMID Study Product Template DMID Specimen Protocol Template: Greater Than Minimal Risk DMID Specimen Protocol Template: Greater Than Minimal Risk DMID Specimen Protocol Template: Minimal Risk DMID Specimen Protocol Template: Minimal Risk

9. ICSSC Protocol Development Services (2) In-depth protocol review/assistance In-depth protocol review/assistance Study design consultationStudy design consultation Statistical considerationsStatistical considerations Implementation planningImplementation planning Data management plansData management plans CRF developmentCRF development Safety reporting and monitoringSafety reporting and monitoring Good Clinical Practices (GCP)Good Clinical Practices (GCP) Informed consentInformed consent Protocol development coordinationProtocol development coordination

10. Process Choose the research question  Develop the concept  WRITE THE PROTOCOL  Revise/finalize the protocol (DMID and IRB approval crucial)  Conduct the study

11. What To Consider When Writing The Protocol (1) Grant proposal vs. study protocol Grant proposal vs. study protocol Narrow down specific aims to objectives Narrow down specific aims to objectives Choose appropriate study design/protocol template Choose appropriate study design/protocol template Eliminate all non-applicable template language from the protocol (use working shell) Eliminate all non-applicable template language from the protocol (use working shell) Minimize duplication/ensure consistency Minimize duplication/ensure consistency

12. What To Consider When Writing The Protocol (2) Provide precise information on study population and case definitions Provide precise information on study population and case definitions List all inclusion/exclusion criteria List all inclusion/exclusion criteria Ensure objectives are linked to study procedures and statistical sections Ensure objectives are linked to study procedures and statistical sections

13. What To Consider When Writing The Protocol (3) Include sufficient detail in protocol sections like Include sufficient detail in protocol sections like Study proceduresStudy procedures Data managementData management Statistical considerations/ analysisStatistical considerations/ analysis Safety monitoring and reportingSafety monitoring and reporting Ethical considerations/ Human subjects protectionEthical considerations/ Human subjects protection …

14. What To Consider When Writing The Protocol (4) Keep up with informed consent issues Keep up with informed consent issues Informed consent(s) included?Informed consent(s) included? Language simple?Language simple? Enough information about the research?Enough information about the research? Sufficient description of all study visits, procedures, samples taken?Sufficient description of all study visits, procedures, samples taken? Required elements included?Required elements included? Separate approval for future use specimen storage?Separate approval for future use specimen storage?

15. Appendices Sample informed consent(s) Sample informed consent(s) Schedule of events/visits Schedule of events/visits Product use directions Product use directions Other special procedures Other special procedures (Data collection forms) (Data collection forms)

16. Protocol Amendments Informed consent and protocol are usually approved together Informed consent and protocol are usually approved together Any change to either document requires DMID and IRB review and approval Any change to either document requires DMID and IRB review and approval

17. Protocol Writing Tips (1) Use consistent formatting Use consistent formatting Include header/footer with version and date information Include header/footer with version and date information Use reasonable margins Use reasonable margins “white space” eases readability Use numbered section, subsection titles Use numbered section, subsection titles

18. Protocol Writing Tips (2) Spell out abbreviations (abbr.) and acronyms (acr.) at first use Spell out abbreviations (abbr.) and acronyms (acr.) at first use Spell out single-digit numbers up to nine Spell out single-digit numbers up to nine Use bulleted lists instead of long paragraphs Use bulleted lists instead of long paragraphs Avoid duplication of information Avoid duplication of information Delete template sections, if not applicable Delete template sections, if not applicable

19. Final Hints Clear, concise protocol critical to study success Clear, concise protocol critical to study success Start early — protocol development takes time Start early — protocol development takes time Early input and internal peer review facilitates approval process later Early input and internal peer review facilitates approval process later Expect multiple reviews — DMID, IRBs and possibly scientific committees generally provide comments Expect multiple reviews — DMID, IRBs and possibly scientific committees generally provide comments

20. Site Assessment Services Site Assessment Services Site assessment - by investigator or DMID request Site assessment - by investigator or DMID request Needs assessment with recommendationsNeeds assessment with recommendations Pre-monitoring assistancePre-monitoring assistance Good Clinical Practices (GCP)Good Clinical Practices (GCP) DM assessmentsDM assessments Clinical site, pharmacy, labClinical site, pharmacy, lab IRBIRB Staff capabilitiesStaff capabilities TrainingTraining

21. Data Management Services Site Assessments Site Assessments Training Training Investigator workshopsInvestigator workshops DM hands on workshopDM hands on workshop At FHIAt FHI Trial Support Trial Support Data management plansData management plans CRF developmentCRF development Data entry systemsData entry systems Documentation and validationDocumentation and validation

22. ICSSC Biostatistics Services (1) Protocol development/implementation Protocol development/implementation Study design consultationStudy design consultation Endpoint definitionEndpoint definition Sample size determinationSample size determination Analysis plan developmentAnalysis plan development DSMB plansDSMB plans Randomization and allocation concealment proceduresRandomization and allocation concealment procedures

23. ICSSC Biostatistics Services (2) Case report forms review Case report forms review DSMB DSMB Interim report preparationInterim report preparation Independent StatisticianIndependent Statistician Final data analysis and interpretation of results Final data analysis and interpretation of results Preparation of final report/manuscripts Preparation of final report/manuscripts

24. ICSSC Training Services Regional clinical research workshops Regional clinical research workshops Fundamentals of clinical researchFundamentals of clinical research Data management workshops Data management workshops Individual data management training at FHI Individual data management training at FHI Ethics Training Ethics Training Scientific writing workshop Scientific writing workshop Assistance with data and manuscript preparation for publication.Assistance with data and manuscript preparation for publication. GCP training GCP training Study Implementation training Study Implementation training

25. Tools & Resources: ICSSC website www.icssc.org www.icssc.org Research Resources Research Resources Presentations Presentations ICSSC Services ICSSC Services Contacts Contacts Request for Assistance Request for Assistance

26. Tools & Resources: WebEx Web-based meeting tool that allows participants to view documents, annotate documents, and perform demonstrations using a variety of software. Web-based meeting tool that allows participants to view documents, annotate documents, and perform demonstrations using a variety of software. Allows investigators to hold on-line meetings between team members located around the world. Allows investigators to hold on-line meetings between team members located around the world. FHI provides international calling support in conjunction with WebEx and has created secure user accounts for all domestic and foreign PIs who have requested the use of WebEx. FHI provides international calling support in conjunction with WebEx and has created secure user accounts for all domestic and foreign PIs who have requested the use of WebEx.

27. Summary ICSSC can provide support during protocol development as well as during the study planning and implementation phases ICSSC can provide support during protocol development as well as during the study planning and implementation phases Contact the ICSSC: http://www.icssc.org/ Contact the ICSSC: http://www.icssc.org/ http://www.icssc.org/