"Clinical Data Management Responsibilites"
Roles & Responsibilities of the Research Team Developed by Center for Cancer Research, National Cancer Institute Endorsed by the CTN SIG Leadership Group Objectives • Define the role of the Principal Investigator • Describe the purpose of FDA Form 1572 • Define the role of an Investigator-Sponsor • Discuss the responsibilities associated with study coordination • Discuss the responsibilities associated with data management • Describe the purpose and contents of a DARF (drug accountability record form) All staff involved in clinical research must adhere to the regulations and understand the guidelines that govern clinical research. Site Perspective • Research Team • Support Staff – Investigator – Clinical/Staff – Study Coordinator / Nurse Research Nurse – Pharmacist – Data Manager – Study Subject Principal Investigator (PI) Responsibilities… • Leads the team that conducts a clinical investigation and is ULTIMATELY accountable for the conduct of the trial • Balances patient coming first with protocol coming first Patient Protocol comes comes first first …PI’s Responsibilities… • Ensures the investigation is conducted according to: – Investigational plan (protocol) – For IND studies, Investigator statement (FDA Form 1572) • Ensures the subjects’: – Rights, safety & welfare are protected …PI’s Responsibilities… • Supervises sub-investigators/educates staff – Protocol – Investigational product – Trial related duties & functions • Assesses time & resources for study conduct …PI’s Responsibilities… • Prepares and maintains adequate case histories (i.e.: medical records/source documents) • Maintains regulatory binder • Discloses financial interest (with own organization, sponsor, and/or FDA) …PI’s Responsibilities… • Obtains informed consent from each subject – Documents consent obtained prior to participation in the study • Reports immediately all serious and unexpected adverse events to IRB and sponsor as applicable • Maintains a record of accreditation for all clinical laboratories used during the investigation …PI’s Responsibilities… • Assures IRB reviews for: – Initial protocol and all amendments – Continuing reviews – Serious adverse events – Data Safety Monitoring Board (DSMB) reviews • Ensure integrity of research data …PI’s Responsibilities… • Controls investigational drug/product: – Supervises administration of drug – Restricts access to drug – Records distribution of drug • Dates • Dose & Quantity • Subjects – Returns or disposes of all unused or partially-used product …PI’s Responsibilities • Makes records available for inspection, as applicable (e.g.: FDA, OHRP, Sponsor, IRB, CCR OCD) • Complies with record-keeping & record retention requirements – Case histories, source documents, consents – Retain for 2 years after NDA approved or, 2 years after investigation is discontinued, or as directed by the sponsor FDA Form 1572 (page 1) • Statement of Investigator Form 1572 • Legal agreement between the PI and the FDA for all studies that use an IND • ONE 1572 per protocol (CTEP studies are exception) • Updated as needed FDA Form 1572 (page 2) Investigator's pledges Site Management Organization (SMO) An independent contractor that assumes 1 or more of the duties of a clinical investigator, not the transfer of responsibilities: – Preparation and maintenance of case histories – Ensuring compliance with IRB review – Submitting protocol amendments to IRB – Maintain a record of accreditation for all laboratories used during the study – Completing case report forms – Submitting data to sponsor Sponsor - Investigator • A physician who both initiates and conducts an investigation and under whose immediate direction the investigational drug is administered or dispensed. • Must adhere to regulations and guidances for BOTH the Investigator and the Sponsor. Associate/Sub-Investigator Responsibilities … • Assists in conducting the investigation according to the investigational plan (protocol) • Assists in obtaining informed consent • Provides accurate/adequate case histories …Associate/Sub-Investigators Responsibilities • Discloses financial interests • Reports immediately all “serious and unexpected” adverse events to the PI • Reports all adverse events to the PI Clinical Trial Nurse (CTN) Primary responsibility is to coordinate daily activities of the trial = hands on control of the trial. AKA: Study Coordinator, Research Nurse CTN Responsibilities: Overview • Study coordination • Maintain the integrity of the protocol • Documentation – Patient data – Deviations & violations • Education – Patient, Staff, Self • Data – Input, output, QA – Analyze data for reporting & presentation CTN Responsibilities… • Coordinates study: – Recruiting – Screening and scheduling patients – Securing informed consent – Study conduct – Initiation, monitoring and close-out visits – Coordination of lab pick-ups, supplies, etc. …CTN Responsibilities… • Maintains accurate and appropriate source documentation, including phone conversations • Reports adverse events - constant vigilance for any AEs • Manages case report forms (CRFs) including data QA & QC • Directs patient care – Provides patient care as indicated …CTN Responsibilities… • Ensures drug accountability & inventory – Assure subject drug compliance • Retains records as per regulations • Archives records as appropriate • Maintains regulatory files …CTN Responsibilities… • Assists PI in preparing protocols and consents, continuing reviews, and publications • Knows the deadlines for IRB and Sponsor/FDA reporting • Documents deviations & violations when necessary …CTN Responsibilities… • Provides staff/clinical nurse education – Schedule in-services for all appropriate nursing units – Present information in a concise manner focusing on what the clinical nurses need to know (drug administration and PKs) – Provide worksheets, as appropriate – Keep staff informed about amendment and general protocol progress … CTN Responsibilities… Patient Education • Provides patient education: – Disease – Clinical Trials & Research: phases, patient role – Importance of compliance with treatment and procedures – Specific protocol for patient • Study objectives • Schema: calendars & visual aids • Side effects & management – Expectations for patient • cure, control, palliation or no benefit? Data Manager (DM) Individual responsible for organizing and collecting the data in a clinical trial. DM Responsibilities: Overview • Source document collection • Data abstraction • Data entry • Provide periodic reports from database • Case Report Form development • Prepare for audits/monitoring visits DM Responsibilities… • Collects source documents needed for data abstraction • Abstracts research data from patient’s medical record/source documents to the case report form (paper or electronic) • Enters data into database(s) • Conducts self-audits to ensure data quality …DM Responsibilities • Manages protocol related data (i.e.: understanding what forms are still outstanding and what documentation is missing) • Understands the various databases used and how to resolve problems associated with the different systems • Provides periodic reports from database • Prepares for audits/monitoring visits Study Subject’s Responsibilities • Adheres to protocol specific schedule of events • Notifies research staff if unable to comply with protocol criteria (e.g.: exclusionary meds, keeping appointments, patient diaries, etc.) • Notifies research staff of change in status (e.g.: new phone #, adverse event, etc.) in a timely manner Support Staff Responsibilities: Staff/Clinic Nurse • Provides direct patient care including treatment and patient education • Adheres to protocol • Documents all patient encounters • Collects specimen as per protocol • Informs PI/CTN of patient or protocol related issues/concerns Support Staff Responsibilities: Pharmacist • Prepares drugs as per protocol • Stores investigational products as per protocol – For multiple studies using same IND agent, needs to provide separate/distinct storage in pharmacy • Maintains accurate drug accountability records – Receipts of drug shipment/invoices – Drug accountability record form (DARF) Example of a DARF Helpful Hints: Know Your Protocols • Eligibility criteria • Drug preparation & administration • Schema, requirements, follow-up – PKs, research tests, restaging, drug return • Dose limiting toxicity and/or dose modifications • Reporting requirements • Results (responses, toxicities) Helpful Hints: Know the Disease • Etiology • Disease Staging • Epidemiology • Treatment Options • Signs and – What is standard Symptoms therapy? • Screening and • Disease Trajectory Diagnosis • Clinical Trials • Pathology Grading elsewhere for the same disease Regardless of Your Role: Be Your Own Best Advocate • Protect your time & get organized • Learn as much as you can about: – clinical trials – oncology – your particular drug(s) – your database/software programs • Know how/where to get training & do it • Join a professional organization & get involved • Teach something new & you will learn • Teach someone new & you will grow Module Evaluation The CTN SIG would greatly appreciate your feedback on this learning module. Please complete the evaluation form and fax to Elizabeth Ness at 301-496-9020.