Title: ICSSC International Clinical Sciences Support Center
1ICSSCInternational Clinical Sciences Support
Center
- Family Health International
2What 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.
3Who is the ICSSC?
4ICSSC Services
- Protocol Development
- Site Assessment
- Data Management
- Biostatistics
- Training
- Etc.
5Where is the ICSSC?
6Requesting Assistance
- New ICIDR.need HELP?
- Contact your DMID Program Officer
- Contact the International Clinical Sciences
Support Center (ICSSC)http//www.icssc.org/
7Study Protocol
ICH GCP 1.44A document that describes the
objective(s), design, methodology, statistical
considerations, and organization of a trial.
8ICSSC 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
9ICSSC 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
10Process
Choose the research question ? Develop the
concept ? WRITE THE PROTOCOL ? Revise/finalize
the protocol (DMID and IRB approval
crucial) ? Conduct the study
11What 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
12What 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
13What 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
14What 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?
15Appendices
- Sample informed consent(s)
- Schedule of events/visits
- Product use directions
- Other special procedures
- (Data collection forms)
16Protocol Amendments
- Informed consent and protocol are usually
approved together - Any change to either document requires DMID and
IRB review and approval
17Protocol 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
18Protocol 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
19Final 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
21Data 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
22ICSSC Biostatistics Services (1)
- Protocol development/implementation
- Study design consultation
- Endpoint definition
- Sample size determination
- Analysis plan development
- DSMB plans
- Randomization and allocation concealment
procedures
23ICSSC 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
24ICSSC 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
25Tools ResourcesICSSC websitewww.icssc.org
- Research Resources
- Presentations
- ICSSC Services
- Contacts
- Request for Assistance
26Tools ResourcesWebEx
- 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.
27Summary
- ICSSC can provide support during protocol
development as well as during the study planning
and implementation phases - Contact the ICSSC http//www.icssc.org/