ICSSC International Clinical Sciences Support Center

1. ICSSCInternational 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 • 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.

3. Who is the ICSSC?

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

5. Where is the ICSSC?

6. Requesting Assistance • New ICIDR….need HELP? • Contact your DMID Program Officer • 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 • Clarity • Completeness • GCP compliance • Proper use of DMID protocol templates http://www.niaid.nih.gov/dmid/clinresearch • DMID Study Product Template • DMID Specimen Protocol Template: Greater Than Minimal Risk • DMID Specimen Protocol Template: Minimal Risk

9. ICSSC Protocol Development Services (2) • In-depth protocol review/assistance • Study design consultation • Statistical considerations • Implementation planning • Data management plans • CRF development • Safety reporting and monitoring • Good Clinical Practices (GCP) • Informed consent • Protocol 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 • Narrow down specific aims to objectives • Choose appropriate study design/protocol template • Eliminate all non-applicable template language from the protocol (use working shell) • Minimize duplication/ensure consistency

12. What To Consider When Writing The Protocol (2) • Provide precise information on study population and case definitions • List all inclusion/exclusion criteria • 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 • Study procedures • Data management • Statistical considerations/ analysis • Safety monitoring and reporting • Ethical considerations/ Human subjects protection • …

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

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

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

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

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

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

20. Site Assessment Services • Site assessment - by investigator or DMID request • Needs assessment with recommendations • Pre-monitoring assistance • Good Clinical Practices (GCP) • DM assessments • Clinical site, pharmacy, lab • IRB • Staff capabilities • Training

21. Data Management Services • Site Assessments • Training • Investigator workshops • DM hands on workshop • At FHI • Trial Support • Data management plans • CRF development • Data entry systems • Documentation and validation

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

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

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

25. Tools & Resources:ICSSC websitewww.icssc.org Research Resources Presentations ICSSC Services Contacts 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. • 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.

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