Presentation on theme: "The Study Coordinator’s Role in Investigator- originated Studies"— Presentation transcript:
1 The Study Coordinator’s Role in Investigator- originated Studies Diane Davies RNManager, Clinical Research UnitHelen Diller Family Comprehensive Cancer CenterConsultant: CTSI and QIU
2 Let’s talk about you, the study coordinator …… Educated, motivated and you like and care about people!!!!As a study coordinator you often become attached to the patients and want what is best for the patients and their families!!!!
3 Skills you bring to the position: Verbal CommunicationWritten CommunicationInformation Technology SkillsProblem SolvingOrganizational SkillsTeamwork with Peers
4 Skills you will acquire as a Study Coordinator: Ethical Conduct-Maintaining Data Integrity, GCP GuidelinesDrug/Device/Biologics DevelopmentClinical Care in a Medical Center SettingClinical Trial Budgets & Financial ManagementMedical and Scientific TerminologyRegulations and Guidelines applicable to Clinical ResearchData ManagementLeadershipTeamwork among Medical Professionals
5 Objectives Define an investigator-originated study Define your role in the 3 stages of a studyPre-study (study set up period)Study Conduct PeriodData Analysis and Closeout
6 An investigator-originated study is defined as… A study that is the PI’s original or collaborative idea.The PI owns the dataThese studies are often sponsored by the NIH or other agencies that grant money for scientific ideas.
7 Other FundingAt UCSF investigators can also use gift or departmental funds to finance a studyDrug manufacturers can also finance this type of study.These studies are usually called Investigator Sponsored Trials or IST’sThe manufacturer will supply the drug/device and may pay per patient enrolled
8 Investigator-originated studies include: Therapeutic (intended to cure or prolong a life)Symptom managementPreventionEarly detection/diagnosticCorrelative – Imaging/ tissue/ bloodPopulation-based studies:Epidemiology/Surveys/ObservationalQuality-of-life
9 The Principal Investigator is responsible for:The entire conduct of the studyProtocol designFunding and approvals from contracts and grantsHuman subject approvalsData collection and analysisPublication of results
10 The investigator must assure the welfare of all subjects enrolled: Subject management:recruitment practices, HIPAA policiesinformed consent processAdverse event identification and reporting:Any serious adverse event must be reported to the UCSF CHR and if your investigator holds an IND or IDE that event must be reported to the FDA through MedWatch reporting program
11 The Investigator and the Study Coordinator SC are hired to “coordinate” the study, you are not “responsible” for the study….. this can be a fine line between you and the PIDeveloping a rapport with your PI:Use the Delegation of Responsibilities Log to start your conversation with the PIThe Log is found on the QUI websiteAsk your PI about their vision of the studyWill this lead to further studiesWill this device or drug provide new informationDo they have plans for an abstract or publication/ timeline
12 The important role of the SC Human Subject ProtectionEnsuring that the study and consent have current CHR approvalThe most current consent is used, the consent process has occurred and all patients questions have been answered.Subject safety, the protocol is followed and all serious adverse events are identified and reported
13 Examples of SC responsibilities CHR applications, renewals and reporting of SAE / protocol violationScheduling subject visits/ collection of biological samplesInterviewing subjects / Collection of questionnairesAbstracting study data into database or Case Report FormsData IntegrityLiaison with Medical CenterStudy Budgets
15 Regulations for Human Subjects Office of Health and Human Services &Office for Human Research Protections (OHRP)Food and Drug AdministrationCode of Federal Regulations21 CFR parts 11, 50, 54, 56, 312, 314, 812, 81445 CFR part 46
16 Committee on Human Research (CHR) applications and renewals The organization that is responsible for providing the infrastructure at UCSF for clinical research is the Human Research Protection Program ( HRPP)Committee on Human Research (CHR) applications and renewalsQuality Improvement Unit (QIU)post approval reporting
17 Clinical & Translational Research Institute The CTSIClinical & Translational Research InstituteFind Consultation ServicesSearch Research Cores at UCSFUse Clinical Research Center
18 CTSI Consulting Services BiostatisticsStudy Design and ImplementationData ManagementEthicsHealth PolicyBioinformatics Data Analysis
19 CTSI Consulting Services Regulatory Knowledge (RKS) ConsultationRegulatory requirements (including FDA and IRB)Interactions with regulatory authoritiesRegulatory strategies across the spectrum of preclinical to late phase clinical research
20 Drugs/Biologics and Devices A investigator who files an IND or IDE application must comply with:Code of Federal Regulations (CFR) title 21 – 312 (FDA regulations)International Conference on Harmonization (ICH) topic E6, Guidelines for Good Clinical Practice (GCP’s)If you need advice contact CTSI- RKS
21 Clinical Research Centers Inpatient and Out-patient locations San Francisco General HospitalMoffitt HospitalMount Zion HospitalMoffitt Pediatrics HospitalTenderloin CenterCHORI Children's HospitalAdults Kaiser Oakland Research UnitVeterans Affairs Medical Center
22 CTSI- Clinical Research Centers Services Nursing ServicesBionutrition Services Body Composition & ExerciseLaboratories Sample ProcessingNewborn Intensive Care Neurodevelopmental Evaluation
23 Prestudy What is the objective of the study? Who is the target population?What are the risks to the subject?How and where is the research conducted?What are your resources?
24 Prestudy CHR application IND/IDE application See your MSO regarding: study budgetyour role with Grants and Contractsspace and work suppliesSee the Clinic Manager and Administrative Nurse for both outpatient and inpatients care areas orientation
25 Take a look at the study events and determine the enrollment plan Recruitment planThe grant application will define the study population and target accrualTips:Where is the study population located, recruitment methods, in person/by letter /by phone or advertisementTake a look at the study events and determine the enrollment plan
26 Make sure your study is registered at Clinical trials Make sure your study is registered at Clinical trials.gov after you receive CHR approval
27 Pre-study data collection preparation The data collection needs to support the study objectivesHow are you going to gather the data?How are you going to record and store the data?Work with the statistician and PI on the data collection methods
28 What is source documentation ? The original recording of data, such as the B/P on a VS sheet, a RN/MD note, clinic note, medication record or infusion records / surgical dictationAny signed notes by care providersTest (lab or image reports) downloaded from STORER recordTelephone notes
29 Pre Study Subject visits- Layout an enrollment schedule – the visit schedule can snowball and resources will not be availablePI/MD timeClinic schedule/OR scheduleInterviewers availabilitySet up a pt. calendar to inform patients of the visits and location of appointment ( Maps/printed directions / parking lots
30 Source documentation you may need to develop Inclusion/ Exclusion checklistDrug compliance diaries or symptom diaries (make sure the subject signs the diary as you collect it)Log to collect adverse eventsLog to collect concomitant medsLog documenting the collection of blood or tissue samples
31 What is an Adverse Event Any change in the subject health, a new symptom, an accident or new diagnosis after the subject has received a drug or device or during a medical procedureThese are documented on all device or drug trials while subjects on studyThey are classified by grade 1-5, or mild, moderate or severe and death. Relationship to the experimental drug or device must be included
32 QuestionnairesWhen using a validated questionnaire you do not need source documentationFACTQOLDepression ScalesMake sure the form has the subject identifier and date of completion- some forms require a signature
33 Case Report Forms (CRF’s) CRF’s is the paper or electronic form that collect the data needed for study analysisPaper vs. Electronic data baseUse unique identifiers (initials and study number)If data is missing indicate by UNKCode entries/ do not use textPE Normal = 1 abnormal= 2 not done =3
34 Your Primary Role in Data Collection is to Maintain Data Integrity Complete and accurate accumulation of information as specified in the study protocolFollowed by the accurate transfer of this information (data) to the data collection methodIt is preferable to use electronic data entry, set –up in secure relational database versus paper forms or an Excel file
35 Prestudy Setting up your files Create a system to keep all approvals in orderIf the study changes, send in an amendment to the CHRRemember to do a CHR yearly renewal
36 Regulatory Files Set-up and Maintain Regulatory Binder or File IRB required on-study documentationInitial approval and approved consentProtocol modificationSingle Subject exceptionsInformed consent modificationsAnnual renewalsOnsite serious adverse eventsOfficial Communication with the CHR
37 Enrollment and Screening Logs Create a log to track all potential subjectsScreening logs (initials and dates/ keep copies of the consents)Enrollment logs:Name, DOB ,contact informationDate of consentDemographics (reporting to granting agencies)Dates of treatment / evaluation or 1st questionnaire
38 Are you ready?Must have full CHR approval including recruitment materials !!!Grant and contracts must have full authorization and final signatures !!!Is the study is registered on Clinical Trials.gov ?Is the Fund/ DPA set up with a ZZ account ?Do you know how to link study subjects on IDX ?
39 Screening and Enrollment Document clearly:Consent procedureDetermining eligibility –time frame of testing is often very importantuse a checklistObtain signatures of the PI/ NP or other supervisorCollect supporting documentationReview with PI and obtain signoffInform the patient of the next steps, who informs the subject that they can participate in the study ??Give study calendar to the subject with projected dates and set up the next appt.Randomization –who will inform the patient if the study is not double blind
40 The subject has been enrolled: What are my next steps?Ensure protocol interventions are carried out in asafe and timely manner per protocol guidelines:ProceduresLaboratory/radiology testsStudy drug administration
41 Study Implementation and Documentation Documentation specific to protocolNote should start with protocol numberInvestigator or staff should clearly document informed consent process and any re-consentingInvestigator / RN should document dosing and dose modifications.Investigator should document relationship of adverse events to study participation, management of event, and when it resolved
42 Study Implementation Data Collection Abstract data from a variety of sources to complete CRFObtain medical reports; forms for off-site officesCreate and maintain source documents/shadow chartsEnter information on the CRF database/paper
43 Study Implementation Maintain study drug supply/devices Shipping receipts, dispensing logDocument communications with “Medical Science Liaison (MSL)” regarding study conductMaintain worksheets for investigator/division to track on-study activities, costs, and scheduling
44 Study conductScheduling subject visits and exam- this can be very time consumingKeep up with the subject data collectionUse study chart (shadow file) to have medical records at your deskDo not forget to set aside time for data entry, double check or have someone audit your dataReview the data with the PI, find out when a presentation or abstract is planned
45 Study Conduct Keep your subject log up to date, track all study visits Review the billing charges to your studyLiason with your dept finance personnelEnter the date off study or completion of studyIf long term follow up of subjects is required - create a method to track the next contact –(use an electronic calendar or excel spreadsheet with calculations
46 The PI and SC relationship Keep your PI and other investigator informed of any changes and updatesMeetings 1:1WeeklyTeam meetingAsk your PI how s/he wants to be informed.What s/he needs to know about immediately, or at the end of the day or in a weekly meeting.
47 The study has ended, what now ?? All subject follow-up has endedAll data is collectedHas the pharmacy been notifiedAll data is entered into a data base and the data base is “lock”If you are not going to be contacting a subject or reviewing medical records the study may be “retired at CHR”Notify the CHR using the study close-out report
48 Data Analysis Discuss your role with the PI Organize the study charts and regulatory filesMake sure the PI has the electronic data and there is data back-upRemind the PI to acknowledge the CTSI on publicationYou may want to send subjects a thank you for their participation and results of the study.
49 Research Protocol Coordination Pre-ActivationRecruitmentTreatment/Activate TeamStudyClose-OutAdverse EventCollectionOn-goingData CollectionTumorResponseAssessmentProtocol Design andFeasibilityPatient/FamilyEducationProtocolModificationsOff-StudyFollow-upPrepareRegulatoryDocumentsInformedConsentEligibilityReport to IRBDoseModificationsReport toSponsor/IRBBegin DataCollectionStaff EducationInitiation MeetingsReport BackTo SponsorOff-StudyFollow-upUpdatePatient andTeamBudget
50 Seven Ethical Principles* Social or scientific valueScientific validityFair subject selectionFavorable risk-benefit ratioIndependent reviewInformed consentRespect for subjects*“What Makes Clinical Research Ethical,” Emanuel.
51 More TrainingCollaborative Institutional Training Initiative – “CITI” required by the CHR for all key personnelClinical Trials Networks Best PracticesMedical Center Annual Safety TrainingSafe Shipping and BiohazardsBlood-borne PathogensVaccinations and TB testing- Occupational Health – see your HR deptResearch Billing (FOT-519)IDX, STOR, U-CARE
52 Study tools from the QUI Below is a collection of tools to assist in the conduct and management of clinical research:Delegation of Authority Documentation LogScreening / Enrollment / Withdrawal LogRegulatory File ChecklistDrug or Biologic Dispensing / Accountability logDevice Dispensing / Accountability LogExample: Study Events Tracking FormExample: Tracking System for Deadlines and Reporting
53 Learn more about your job OrganizationsACRPSOCRAContact Beverly Fein at for local chapter infoResearch Practitioner
54 These sites have information for subjects about participation in clinical trials