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ICSSCICSSCInternational Clinical International Clinical

Sciences Support CenterSciences Support Center

Family Health InternationalFamily Health International

What is the ICSSC?What is the ICSSC? DMID contract for investigators funded by DMID contract for investigators funded by

NIH/NIAID/DMID conducting research at NIH/NIAID/DMID conducting research at resource-constrained foreign sitesresource-constrained foreign sites

Located at Family Health International (FHI), Located at Family Health International (FHI), a diverse public health research organization a diverse public health research organization working mainly in the developing world.working mainly in the developing world.

Composed of an interdisciplinary team of Composed of an interdisciplinary team of experts in various areas of clinical research.experts in various areas of clinical research.

Logistics/ Event Planners

Study Design/

Methodology Experts

Biostatisticians

Data Managers

Clinical Trials/

Protocol Specialists

Who is the ICSSC?

Who is the ICSSC?Who is the ICSSC?

ICSSC ServicesICSSC Services

Protocol DevelopmentProtocol Development Site AssessmentSite Assessment Data ManagementData Management BiostatisticsBiostatistics TrainingTraining Etc.Etc.

Where is the ICSSC?Where is the ICSSC?

Requesting AssistanceRequesting Assistance

New ICIDR….need HELP?New ICIDR….need HELP?• Contact your DMID Program OfficerContact your DMID Program Officer• Contact the International Clinical Contact the International Clinical

Sciences Support Center (ICSSC)Sciences Support Center (ICSSC)

http://www.icssc.org/http://www.icssc.org/

Study ProtocolStudy Protocol

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

ICSSC Protocol Development ICSSC Protocol Development Services (1)Services (1)

Protocol Pre-Review Protocol Pre-Review • ClarityClarity• CompletenessCompleteness• GCP compliance GCP compliance • Proper use of DMID protocol templates Proper use of DMID protocol templates

http://www.niaid.nih.gov/dmid/clinresearchhttp://www.niaid.nih.gov/dmid/clinresearch DMID Study Product TemplateDMID Study Product Template DMID Specimen Protocol Template: Greater Than DMID Specimen Protocol Template: Greater Than

Minimal RiskMinimal Risk DMID Specimen Protocol Template: Minimal RiskDMID Specimen Protocol Template: Minimal Risk

ICSSC Protocol Development ICSSC Protocol Development Services (2)Services (2)

In-depth protocol review/assistanceIn-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

ProcessProcess

Choose the research question

Develop the concept

WRITE THE PROTOCOL

Revise/finalize the protocol (DMID and IRB approval crucial)

Conduct the study

What To Consider When Writing What To Consider When Writing The Protocol (1)The Protocol (1)

Grant proposal vs. study protocolGrant proposal vs. study protocol Narrow down specific aims to objectivesNarrow down specific aims to objectives Choose appropriate study design/protocol Choose appropriate study design/protocol

templatetemplate Eliminate all non-applicable template Eliminate all non-applicable template

language from the protocol (use working language from the protocol (use working shell)shell)

Minimize duplication/ensure consistencyMinimize duplication/ensure consistency

What To Consider When Writing What To Consider When Writing The Protocol (2)The Protocol (2)

Provide precise information on study Provide precise information on study population and case definitionspopulation and case definitions

List List allall inclusion/exclusion criteria inclusion/exclusion criteria Ensure objectives are linked to study Ensure objectives are linked to study

procedures and statistical sectionsprocedures and statistical sections

What To Consider When Writing What To Consider When Writing The Protocol (3)The Protocol (3)

Include sufficient detail in protocol Include sufficient detail in protocol sections likesections like• Study proceduresStudy procedures• Data managementData management• Statistical considerations/ analysisStatistical considerations/ analysis• Safety monitoring and reportingSafety monitoring and reporting• Ethical considerations/ Human Ethical considerations/ Human

subjects protection subjects protection • ……

What To Consider When Writing What To Consider When Writing The Protocol (4)The Protocol (4)

Keep up with informed consent issuesKeep 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, Sufficient description of all study visits,

procedures, samples taken?procedures, samples taken?• Required elements included?Required elements included?• Separate approval for future use Separate approval for future use

specimen storage?specimen storage?

AppendicesAppendices

Sample informed consent(s) Sample informed consent(s) Schedule of events/visitsSchedule of events/visits Product use directionsProduct use directions Other special proceduresOther special procedures (Data collection forms)(Data collection forms)

Protocol AmendmentsProtocol Amendments

Informed consent and Informed consent and protocol are usually approved protocol are usually approved togethertogether

Any change to either Any change to either document requires DMID and document requires DMID and IRB review and approvalIRB review and approval

Protocol Writing Tips (1)Protocol Writing Tips (1)

Use consistent formattingUse consistent formatting Include header/footer with version Include header/footer with version

and date informationand date information Use reasonable margins Use reasonable margins

““white space” eases readabilitywhite space” eases readability Use numbered section, subsection Use numbered section, subsection

titles titles

Protocol Writing Tips (2)Protocol Writing Tips (2)

Spell out abbreviations (abbr.) and Spell out abbreviations (abbr.) and acronyms (acr.) at first useacronyms (acr.) at first use

Spell out single-digit numbers up to nineSpell out single-digit numbers up to nine Use bulleted lists instead of long Use bulleted lists instead of long

paragraphsparagraphs Avoid duplication of informationAvoid duplication of information Delete template sections, if not Delete template sections, if not

applicableapplicable

Final HintsFinal Hints Clear, concise protocol critical to study Clear, concise protocol critical to study

successsuccess Start early — Start early —

protocol development takes timeprotocol development takes time Early input and internal peer review Early input and internal peer review

facilitates approval process laterfacilitates approval process later Expect multiple reviews — Expect multiple reviews —

DMID, IRBs and possibly scientific DMID, IRBs and possibly scientific committees generally provide commentscommittees generally provide comments

Site Assessment ServicesSite Assessment Services Site assessment - Site assessment - by investigator or by investigator or

DMID requestDMID request

• Needs assessment with Needs assessment with recommendationsrecommendations

• 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

Data Management ServicesData Management Services

Site AssessmentsSite Assessments TrainingTraining

• Investigator workshopsInvestigator workshops• DM hands on workshopDM hands on workshop• At FHIAt FHI

Trial SupportTrial Support• Data management plansData management plans• CRF developmentCRF development• Data entry systemsData entry systems• Documentation and validationDocumentation and validation

ICSSC Biostatistics Services (1)ICSSC Biostatistics Services (1)

Protocol Protocol development/implementationdevelopment/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 Randomization and allocation

concealment proceduresconcealment procedures

ICSSC Biostatistics Services (2)ICSSC Biostatistics Services (2)

Case report forms reviewCase report forms review DSMBDSMB

• Interim report preparationInterim report preparation• Independent StatisticianIndependent Statistician

Final data analysis and Final data analysis and interpretation of resultsinterpretation of results

Preparation of final Preparation of final report/manuscriptsreport/manuscripts

ICSSC Training ServicesICSSC Training Services Regional clinical research workshopsRegional clinical research workshops

• Fundamentals of clinical researchFundamentals of clinical research Data management workshopsData management workshops Individual data management training at FHIIndividual data management training at FHI Ethics TrainingEthics Training Scientific writing workshopScientific writing workshop

• Assistance with data and manuscript preparation Assistance with data and manuscript preparation for publication.for publication.

GCP trainingGCP training Study Implementation trainingStudy Implementation training

Tools & Resources:Tools & Resources:ICSSC websiteICSSC websitewww.icssc.orgwww.icssc.org

Research ResourcesResearch Resources PresentationsPresentations ICSSC ServicesICSSC Services ContactsContacts Request for AssistanceRequest for Assistance

Tools & Resources:Tools & Resources:WebExWebEx

Web-based meeting tool that allows Web-based meeting tool that allows participants to view documents, annotate participants to view documents, annotate documents, and perform demonstrations documents, and perform demonstrations using a variety of software. using a variety of software.

Allows investigators to hold on-line Allows investigators to hold on-line meetings between team members located meetings between team members located around the world. around the world.

FHI provides international calling support in FHI provides international calling support in conjunction with WebEx and has created conjunction with WebEx and has created secure user accounts for all domestic and secure user accounts for all domestic and foreign PIs who have requested the use of foreign PIs who have requested the use of WebEx. WebEx.

SummarySummary

ICSSC can provide support ICSSC can provide support during protocol development as during protocol development as well as during the study well as during the study planning and implementation planning and implementation phasesphases

Contact the ICSSC: Contact the ICSSC: http://www.icssc.org/http://www.icssc.org/