Investigator Responsibilities in Clinical Research: Insights and helpful hints for researchers

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1 Investigator Responsibilities in Clinical Research: Insights and helpful hints for researchers ITHS Clinical Research Education Series September 7, 2010

2 Objectives Understanding the requirements of DHHS Form 1572 Defining adequate training of the research team Tools for maintaining supervision of the research team 2

3 Investigator Responsibilities Overview of federal regulation of clinical research Commonly encountered problems Understanding investigator responsibilities How can it be done? 3

4 Federal Regulation of Clinical Research Department of Health and Human Services (DHHS) NIH FDA 45 CFR 46, CFR 11, 50, 54, 56, 312, 314, 600, 803, 812, 814 4

5 Clinical Trials Oversight: FDA vs. OHRP FDA oversight Sponsors, monitors, clinical investigators, contract research organizations involved in IND/IDE studies IRBs reviewing clinical research involving any FDAregulated product (IND/IDE and non-ind studies) OHRP oversight Institutions where clinical research is conducted or supported by HHS or Institutions that agree to assume responsibility for the research in accordance with 45 CFR 46 regardless of the funding source 5

6 FDA Bioresearch Monitoring Program (BIMO) Under FDAs Division of Scientific Investigations A comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA regulated research Can be for cause or routine Potential findings OAI = official action indicated (warning letters) VAI = voluntary action indicated NAI = no action indicated 6

7 Complaints Received at the FDA: *Calendar Years Tejashri Purohit-Sheth, M.D.FDA,CDER

8 What Are the Allegations? Informed Consent Issues Drug accountability Falsification Recruitment Practices Failure to report adverse events Failure to follow the protocol Inadequate Records Qualifications of persons performing physicals Failure to get IRB approval, report changes in research Poor Supervision No active IND Violations of GLP regs Monitoring practices Blinding Charging for the test article Misleading advertisements Failure to follow FDA regulations Lewin C FDA,CDER

9 Prevalence of OAI Inspections (DSI data) 1% Routine inspections 7023 total cases OAI 1% 85 cases (1.2%) OAI cases Directed inspections OAI 17% 886 total cases 156 (17.6%) OAI cases Lewin C FDA,CDER 2006 JAN SEP

10 You failed to: FDA Comments Report promptly to the Institutional Review Board (IRB) all unanticipated problems involving risk to human subjects or others [21 CFR ]. Ensure that the studies were conducted according to the approved protocols [21 CFR ]. Maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual [21 CFR (b)]. Protect the rights, safety, and welfare of subjects under your care [21 CFR ]. Maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects [21 CFR (a)]. 10

11 Understanding investigator responsibilities

12 Blame for Poor Trial Conduct Investigator s Report 4% 4% 9% Sub-P.I. Monitor 39% FDA/IRB/Institution Position 100% 9% 9% Office Staff P.I. Sponsor Hospital Nurse Study Coordinator P.I. 9% 17% n (parties blamed) = 23; n (cases) = 20 Woollen, S.W., CDER, FDA,

13 Investigator Responsibilites 1. Personally conduct or supervise the investigation 2. Ensure that all associates, colleagues, and employees assisting in study conduct are informed about their obligations 3. Conduct the study in accordance with the protocol 4. Comply with all requirements regarding obligations of clinical investigators [21CFR 312] 5. Inform subjects drugs are being used for investigational purposes and ensure informed consent and IRB requirements are met FDA Form

14 Investigator Responsibilites 6. Obtain initial and continuing review and approval from the IRB. Promptly report to the IRB all changes in the research activity and all unanticipated problems and make no changes in the research without IRB approval 8. Maintain adequate and accurate records 9. Report Adverse Events to the sponsor/irb 10. Read and understand the investigator s brochure FDA Form

15 Excerpts of DHHS Form 1572

16 Who should sign the 1572 as a subinvestigator? Individuals performing significant clinical investigation-related duties e.g. Research fellows Research coordinator who recruits subjects and maintains study records FDA Information sheet guidance for sponsors, clinical investigators, and IRBs: Frequently asked questions statement of investigator (Form FDA 1572)

17 IDE trials require a statement of investigator not Form 1572 A sponsor shall obtain from each participating investigator a signed agreement that includes: 1. The investigator's curriculum vitae. 2. A statement of the investigator's relevant experience. 3. If the investigator was involved in an investigation or other research that was terminated, an explanation of the circumstances that led to termination. 4. A statement of the investigator's commitment to: (i) Conduct the investigation in accordance with the agreement, the investigational plan, this part and other applicable FDA regulations, and conditions of approval imposed by the reviewing IRB or FDA; (ii) Supervise all testing of the device involving human subjects; and (iii) Ensure that the requirements for obtaining informed consent are met. 5. Accurate financial disclosure information. Excerpted from 21 CFR (c) 17

18 I don t do IND/IDE trials how does this apply to me?

19 Lack of adequate trial supervision results in: Poor data Frustrated staff Study delays Risk to subjects Risk for audit by IRB/OHRP 19

20 So what does it mean to personally conduct or supervise the investigation I can t do it all!

21 How can this be done? Appropriate delegation Adequate training Adequate supervision FDA guidance for industry: Investigator responsibilities - protecting the rights, safety and welfare of study subjects

22 What is appropriate delegation of study- related tasks? The investigator should ensure that any individual to whom a task is delegated is: qualified by education, training State licensure (where applicable), and experience to perform the delegated task. FDA guidance for industry: Investigator responsibilities - protecting the rights, safety and welfare of study subjects

23 How can this be documented? Maintain a list of qualified persons to whom the study-specific task has been delegated Describes the delegated tasks Identifies the qualifying training Identifies the dates of involvement in the study 23

24 Dr. Right PRINCIPAL INVESTIGATOR Heads the team Dr. Smart SUB-INVESTIGATOR Assists with consents and performs physicals RN/Coordinator Manages the study, paper flow, and administers drug Coordinator Regulatory functions Helps with recruitment EVERYONE ELSE Lab techs X ray techs etc. Generate an organization chart for yourself Identify the people you need to get the job done Put their specific responsibilities on paper and give it to them Review responsibilities and adherence at set intervals When someone leaves make sure all new credentialing is done 24

25 Sample study specific task chart Study task Specific action Responsible? Screen Telephone screening of interested subjects Screening checklist RC (name) Eligibility Initial review w/ potential subject RC Final eligibility assessment Consent Obtain Informed Consent PI/MD Clinical Procedures Blood draw RN Interim History/Physical exam RC PI PI/MD Source Document Source document for study data RC & PI Data Entry RC Review of source documents RC Toxicity Monitoring Monitoring/review of AEs PI/PI 25

26 Title/Study #: Principal Investigator Coordinator: Facility/Department/Division: *Record staff responsibilities using the following codes, list all that apply: A) Subject Recruitment E) Administers Study Medications B) Obtains Informed Consent F) Drug Accountability C) Performs Study Assessments G) Regulatory Reporting/Paperwork D) Assesses Subject for Adverse Events H) Data Management I) Other: Study Personnel Printed Name Title Study Personnel Role (e.g. PI, Investigator, Coordinator, Pharmacist, etc.) Responsibilities* (List all letters that apply) Signature of Study Personnel Initials of Study Personnel CV on file Obligation Start Date End Date PI Signature and Date 26

27 Examples of inappropriate delegation of study-related tasks Assessment of inclusion/exclusion criteria conducted by individuals with inadequate medical training Physical examinations performed by unqualified personnel Evaluation of adverse events by individuals lacking appropriate medical training or knowledge of the clinical protocol or study agent Assessments of primary study endpoints by individuals lacking appropriate medical training and knowledge of the protocol Informed consent obtained by individuals who lack the medical training and knowledge of the protocol needed to be able to discuss the risks and benefits of a clinical trial 27

28 What is adequate training? Have a general familiarity with the study and the protocol Have a specific understanding of the details of the protocol and the investigational product (if applicable), relevant to the tasks they will be performing FDA guidance for industry: Investigator responsibilities - protecting the rights, safety and welfare of study subjects

29 If someone else wrote the protocol READ THE PROTOCOL Make sure everyone on the research team reads the protocol 29

30 FDA Audits CRITICAL ISSUES Study entry recorded? Signed consent form? Diagnosis documented? Study raw data available? IRB approval at all stages? Amount of drug used coincide with number of subjects? Drug properly disposed? Randomization scheme followed? MOST COMMON DEFICIENCIES Failure to follow the protocol Violation of entry criteria Failure to perform required tests Failure to maintain adequate records No source documents Inaccurate or incomplete source documents Salewski, J.P., CDER,

31 Clinical Investigator Deficiencies CDER Inspections - FY 2005* 74% 51% 63% 57% 48% 36% Foreign Domestic 17% 10% 9% 11% 10% 5% Protocol NAI Record AEs Consent Drug Acct 80% 70% 60% 50% 40% 30% 20% 10% 0% Foreign n = 65; Domestic n =

32 If you are writing the protocol Make it simple, clear and easy to understand Write in reasonable flexibility Write a good safety and monitoring plan Determine which procedures can be done by non-physician staff Assure feasibility Staff Resources Budget 32

33 What is adequate training? Personnel are informed of any pertinent changes during the conduct of the trial and educated or given additional training as appropriate FDA guidance for industry: Investigator responsibilities - protecting the rights, safety and welfare of study subjects

34 What is adequate training? Know the regulatory requirements and standards for the conduct of clinical trials Are competent to perform the tasks that they are delegated FDA guidance for industry: Investigator responsibilities - protecting the rights, safety and welfare of study subjects

35 Examples of required/recommended training Human subjects protection training Good Clinical Practice training Protocol-specific training 35

36 Sample training documentation chart Study personnel Specific study tasks performed Type of training/ certification Date of training Research Coordinator (name) Subject screening Maintenance of source documentation HSP GCP Protocol specific training by PI 4/12/2006 7/5/2007 2/12/2008 Research nurse (name) Study drug infusion HSP GCP RN license Protocol specific training by PI 11/2/2004 3/7/ /12/

37 What is adequate supervision? Identify a distinct individual who has supervisory responsibility (usually the PI) Sub-investigators report to the PI Sub-investigators do not have the primary supervisory responsibility for the site PI should have sufficient time to conduct and supervise the trial Level of supervision should be appropriate to the staff, nature of trial and subject population FDA guidance for industry: Investigator responsibilities - protecting the rights, safety and welfare of study subjects

38 What is adequate supervision of study conduct? Conduct regular meetings with staff Review basic science and clinical issues Review trial progress Update staff on any changes to the protocol or other procedures Review adverse events set plans Review deviations/violations FDA guidance for industry: Investigator responsibilities - protecting the rights, safety and welfare of study subjects

39 What is adequate supervision of study conduct? Establish procedures for ensuring that the consent process is being conducted in accordance with what was approved by the IRB and that study subjects understand the nature of their participation, risks, etc. FDA guidance for industry: Investigator responsibilities - protecting the rights, safety and welfare of study subjects

40 Assuring proper informed consent procedures Review recruitment and approach procedures Assure that anyone who obtains consent* thoroughly understands the protocol Use of consent tools to document process *consent can only be obtained by personnel with the training necessary to adequately explain procedures, risks, benefits, etc. 40

41 Study number Version number IRB date stamp Date consent was signed Time 1. Information about the study, including all available options, was provided in a language that the subject can understand. 2. The subject was given ample opportunity to consider all available options. 3. Questions were elicited and all answers given prior to signing consent. 4. The investigator or sub-investigator is comfortable that by providing adequate information to the subject there is no likelihood of coercion. 5. Verification of comprehension was done in one of the following ways (select at least one of the following): A) The subject asked relevant questions during the informed consent process. B) The clinician asked the subject specific questions about the study. C) The clinician asked the subject to repeat information discussed. 6. The following items were covered when discussing the informed consent for a study with the subject: a) The study involves research. b) Participation is voluntary c) Subjects can decide not to participate or withdraw at any time without penalty or loss of benefits. d) The purpose, duration of study, and issue of randomization/blinding e) The number of screening, pre-entry, entry and on-study visits. f) The length of follow up, what happens in case of early withdrawal, and the reasons for which a subject might be involuntarily discontinued from the study. g) Risks of study treatments and procedures, including psychosocial ones. h) Possible benefits, and if none, this should be stated. i) Reimbursement to subjects, if any. j) Costs to subject. What happens in case of research-related injury or side effects. k) What happens in case of pregnancy, if applicable. l) New findings will be communicated to them. m)confidentiality of data. n) Phone numbers for questions at a later time, including research questions, questions related to subject s rights, and research-related injuries. 7. Copy of consent given to subject. 8. HIPAA consent signed, if required. Comments: Clinician signature Date

42 What is adequate supervision of study conduct? Establish procedures for ensuring study staff comply with the protocol, adverse event assessment and reporting, and other medical issues that arise during the course of the study. FDA guidance for industry: Investigator responsibilities - protecting the rights, safety and welfare of study subjects

43 What is adequate supervision of study conduct? Establish procedures for correcting problems Establish procedures for documenting the performance of delegated tasks FDA guidance for industry: Investigator responsibilities - protecting the rights, safety and welfare of study subjects

44 What is adequate supervision of study conduct? Ensure that source data are accurate, contemporaneous and original Ensure that information in source documents is accurately captured on the Case Report Forms Establish procedures for dealing with data queries and discrepancies FDA guidance for industry: Investigator responsibilities - protecting the rights, safety and welfare of study subjects

45 What about outside parties? PI is considered responsible Lab at local site or contracted by PI Pharmacy at local site or contracted by PI Staff not under PI s direct employment if working at local site Sponsor is considered responsible Central laboratory retained by sponsor FDA guidance for industry: Investigator responsibilities - protecting the rights, safety and welfare of study subjects

46 Protecting the Rights, Safety, and Welfare of Study Subjects During and following the trial, ensure adequate medical care is provided for any adverse events related to the trial. Clinical investigators should be available to subjects during the conduct of the trial at their site. FDA guidance for industry: Investigator responsibilities - protecting the rights, safety and welfare of study subjects

47 Protecting the Rights, Safety, and Welfare of Study Subjects Failure to adhere to the protocol may be considered a failure to protect the rights, safety, and welfare of subjects. Non-compliance with inclusion/exclusion criteria Failure to perform safety assessments in a timely manner FDA guidance for industry: Investigator responsibilities - protecting the rights, safety and welfare of study subjects

48 Additional Tools and Templates Standard Operating Procedures Study Start-up Checklist Study Implementation Checklist Study Team Meeting Minutes Adverse Event Log Protocol Deviation Logs ITHS Forms - 48

49 Resources Institute for Translational Health Sciences (ITHS) Additional education UW Clinical trials handbook https://www.washington.edu/research/clinical-research-handbook// ITHS Regulatory Support and Bioethics Core and Translational Research Toolkit UW Healthlinks Toolkits Translational ResearchToolkit PRIMER toolkit - 49

50 Questions?

51 Next CRES presentation October 5 th 12 noon T625 Responsibilities of the Research Staff

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