PAMQuIP Delegation of Clinical Trial TasksConducting a clinical trial involves the careful coordination of multiple time-sensitive and detailed tasks. Listed below are common tasks involved in the execution of a clinical trial. Research teams should ensure that these tasks, if applicable to the study, are delegated to an individual qualified by education, training and experience to perform the delegated tasks.

PAMQuIP Recommendation: Review the common study tasks listed in the tables. Please customize the list by adding, editing or removing tasks as appropriate and note which team member the task has been delegated to.

Administrative Activities Task Delegated To: Organize and manage Scientific Review SubmissionOrganize and manage IRB/IBC SubmissionSchedule and coordinate protocol specific testsRespond to inquiries regarding eligibility and enrollmentCreate and implement recruitment strategiesMaintain study regulatory documentationDSMB CoordinationTrack Unanticipated ProblemsCommunicate with SponsorLog CITI training

Clinical Activities Task Delegated To:Identify eligible patientsAssess inclusion/exclusion criteriaInforming patients of research and eligibilityParticipate in obtaining informed consentsAssess response to therapyAssess toxicitiesCompletion of scales/questionnaireObtain medical record documentation Identify study variables and source documents

Research-Related Activities Task Delegated To:Protocol design

Adapted with Permission from Boston Children’s Hospital 2013 VCU 2018 version

Case Report Form design, review and testingDevelop the Manual of Operations (MOO)Develop randomization plan and methodsEnsure proper training of research staffAttend investigators meetingFinal report/manuscript preparationDSMB organization and policiesUpdate Roster regularly

Project Management Activities Task Delegated To:Patient registration/randomizationCoordinate with Research PharmacyCoordinate with Central labRecruitment follow-upComplete Case Report FormsCollaborate with and assist the Sponsor’s monitorQueries resolutionReporting serous adverse events (SAE)Maintain investigator filePrepare and/or attend auditsPerform data management and quality assurance checks Ensure CVs are less then 2 years old, signed and dated

Data Management and Statistics Task Delegated To:Database set-up and testingData entry Statistical analysisData cleaning

Adapted with Permission from Boston Children’s Hospital 2013 VCU 2018 version