PREP Course #6 Research Documentation. Presented by: Office of Research Compliance Evelyn Huang, MPH, CCRA, CCRC & Leah Shuchter, MPH

Transcription

1 PREP Course #6 Research Documentation Presented by: Office of Research Compliance Evelyn Huang, MPH, CCRA, CCRC & Leah Shuchter, MPH

2 CME Disclosure Statement The North Shore LIJ Health System adheres to the ACCME s new Standards for Commercial Support. Any individuals in a position to control the content of a CME activity, including faculty, planners, and managers, are required to disclose all financial relationships with commercial interests. All identified potential conflicts of interest are thoroughly vetted by the North Shore-LIJ for fair balance and scientific objectivity and to ensure appropriateness of patient care recommendations. Course Director, Kevin Tracey, has disclosed a commercial interest in Setpoint, Inc. as the cofounder, for stock and consulting support. He has resolved his conflicts by identifying a faculty member to conduct content review of this program who has no conflicts. Evelyn Huang and Leah Shuchter have nothing to disclose

3 Today s Objectives Discuss the importance of good documentation practice in clinical research Apply A.L.C.O.A. for achieving high quality of research data

4 Contents What is Good Documentation Practice? What is A.L.C.O.A.? Case Study Group Discussion

5 You enter the world of research?

6 Regulatory Environment and the Investigator State NSLIJHS Federal GCP Investigator

7 Valid Scientific Contribution To produce credible and reliable data while protecting the rights and welfare of subjects. The way the research is conducted is directly related to the protection of the subject and the quality of the data that s produced. When we produce high quality data, we can be confident in the value of our scientific contribution. Your research provides generalizable knowledge when it is shared with others (publication, conferences, symposiums, sharing with other researchers). To accomplish this goal, we must adhere to Good Clinical Practices as well as Federal, State, and institutional (NSLIJHS) requirements. 7

8 Study-Related Activities that Require Evidence Adequate PI supervision Adequate delegation of authority Protection of the rights, safety, welfare of subjects Inclusion of eligible subjects Informed consent Copy of consent was given AEs, SAEs, Unanticipated Problems Medical care of trial subjects Control investigational product (if applicable) Accurate case histories Protocol Compliance Deviations, Exceptions, Violations Collection and submission of accurate data Subject Screening and enrollment Activities at study-related visits Grant and financial management 8

9 Achieving Data Integrity through Good Practices Transparency The information is easily accessible, readily understood, and clearly described. Eliminate the guess work. 9

10 Good Documentation Practices are the set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner. Transparency Consistency Atypical Circumstanc es Corrective and Preventive Actions Good Documentat ion Practice 10

11 Fundamental Elements of Data Quality Is your documentation ALCOA compliant? A Attributable Does the documentation clearly demonstrate: Who created the record and when, What happened, and When it occurred? L Legible Can the information be easily read and understood? C Contemporaneous - Was the information documented with timeliness? Complete Does the documentation include all of the necessary information? O Original Did you maintain the source of the information (see GCP Glossary, Sections 1.51 and 1.52)? A Accurate Does the information represent what actually happened? Adapted from - FDA - GUIDANCE FOR INDUSTRY - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS - ALCOA

12 Attributable It is expected that data can be linked to its source, attributable to the individual who observed and recorded the data; and traceable to the source of the data itself. Legible Must be readable Contemporaneous Recording information with timeliness. Complete Includes all essential elements Original Source Accurate Free from error; correct; reflects what actually happened. Conforms exactly to truth or standard (the protocol) Stan Woolen, Data Quality and the Origin of ALCOA, The Compass Summer 2010, Newsletter of the Southern Regional Chapter of Quality Assurance

13 Source Documents The foundation of study data: Where information was first recorded Original documents, data, and records Supports subject eligibility, enrollment, and protocol required data Validates data transcribed into the CRFs Source should be maintained in the subject s file. Case Report Forms Used to submit data for analysis: Captures procedures required for each visit per protocol Signed, initialed and dated by person completing CRF May be electronic or paper Note - Some CRFs may also be source documents (e.g. diaries, questionnaires or where data is directly entered onto a form). The Source is considered the most valid information because it represents the origin of the data. Therefore the source should never be altered. 13

14 Source Document Examples Medical records Clinical & office charts Labs Questionnaires Subject diaries Randomization records Rx or device dispensing records X-rays, ECGs, scans Microfiches Data from automated instruments Progress notes Notes to file Source should not be altered 14

15 Case Report Form Examples CRFs help to ensure standardized data collection in your study. They should be signed/initialed and dated by the person collecting the information. 15

16 Recording Data on CRFs Use ALCOA and complete as per protocol/sop Data reported on the CRF, that are derived from source documents, should be consistent with the source documents or the discrepancies should be explained Make corrections appropriately Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not obscure the original entry (i.e. an audit trail should be maintained); this applies to both written and electronic changes or corrections 16

17 What CRF Documentation Issues Can You Find? 17

18 Good Documentation Tips -1 Signature logs must be maintained, indicating each study personnel s printed name, signature and date Changes to hand made entries are not done unless an adequate explanation is annotated, initialed and dated Any changes to research records are done in a manner that does not render the original entry illegible - Don t obliterate original entries Ex: 2/28/10 2/28/11 E.K. 2/29/11 Line through the original data, clearly document the change right next to it, and initial and date. Do not use White-out to make corrections 18

19 Good Documentation Tips -2 Don t back date, always provide a true date with your signature If something is not clear, write a note to file -use these wisely and ensure to have a corrective and preventive action plan as applicable Use indelible (water-resistant) blue or black ink so that it doesn't fade over time or smudge if it gets wet. No pencils or felt-tipped markers allowed Enter data directly in the controlled record and never on a piece of scrap paper in the interim Make sure the entries are accurate and legible so that anyone can understand your entries

20 Top Documentation Issues Internal Audits Northshore-LIJ Health System Audit and IRB Data Consent Forms: Missing original consent form without adequate documentation Completion issues (missing signature and/or date of witness or investigator; tiers incomplete) Inconsistent dates of signing parties Regulatory: Incomplete staff signature/delegation log No subject study enrollment note or documentation of progress on trial Study Conduct: Clinical significance for abnormal lab results not documented on the reports AEs not reported on CRF Incomplete documentation regarding the investigational drug/device accountability 20

21 Top Documentation Issues External Audits FDA Warning Letter Data 1 Adhering to the protocol failure to: follow inclusion/exclusion criteria/document how exclusion criteria were met perform protocol-required testing within appropriate time frame or perform assessments/procedures report SAEs to sponsor/recording AEs on CRFs Maintaining adequate subject records failure to: maintain adequate case histories record overall observations maintain accurate records regarding receipt, use, and disposition of device 1. Top Ten FDA Warning Letter Findings from

22 Top Documentation Issues External Audits FDA Warning Letter Data Adequately protecting human subjects failure to: document informed consent through use of a written IRB approved consent form include all required elements in the consent form Assuring proper IRB approval failure to: promptly report to the IRB all changes in research activity obtain IRB approval for changes prior to implementing changes 22

23 Short Exercise FDA issued a warning letter to the PI: 1. You failed to promptly report to the IRB all unanticipated problems involving risk to human subjects [21 CFR and ] : PI did not report the following events to IRB: 1 subject died, and 1 was hospitalized. However, no documentation indicates that PI promptly reported to IRB 2. You failed to obtain and adequately document informed consent in accordance with 21 CFR 50 : for 30 of the 34 subjects enolled, informed consent was not obtained or documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent. 23

24 Short Exercise 3. You failed to prepare and maintain adequate and accurate case histories that record all observations and data pertinent to the investigation on each individual [21 CFR (b)]. : PI did not document the six-month follow-up that was conducted via telephone in the case histories for 22 subjects FDA required: Within fifteen (15) working days of PI s receipt of this letter, PI should notify the office in writing of the actions he/she has taken or will be taking to prevent similar violations in the future. Failure to adequately and promptly explain the violations noted above may result in regulatory action without further notice. 24

25 Short Exercise What are the bad documentation practices here? What would you recommend for improving the documentation practices including the process? 25

26 Research Compliance Tools and Guidance Go to: Click on Tools and Guidance 26

27 Questions? 27

28 Thank You Contact the ORC for any questions Evelyn Huang Manager, Research Compliance Phone: (516) Leah Shuchter Manager, Research Compliance Phone: (516) Emmelyn Kim Director Phone: (516)