Essential Documents For the Conduct of a Clinical Trial(1)

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					                                    QUALITY ASSURANCE GUIDELINES

      Essential Documentation For the Conduct of Research involving Human Subjects For
                      Protocols that Present More Than Minimal Risk

I.         PURPOSE
          The purpose of the guidelines is to ensure that all researchers and their staffs have a
          consistent process that meets regulatory and institutional standards. Adhering to these
          guidelines provides a system that documents protocol compliance and research subject
          safety, as well as ensuring favorable audits by external agencies and sponsors.

          The investigator is held responsible that all of his/her staff are informed concerning their
          obligations under federal, state regulations, as well as institutional policies and

          The documents listed below individually and collectively permit evaluation of the
          conduct of a trial and the quality of the data produced. These documents serve to
          demonstrate the compliance of the investigator, sponsor, and monitor with all regulatory
          requirements and institutional standards.

                    A.        Regulatory Documents
                              1. CCI/IRB Research Application.
                                   Note: Members of the Research Team who obtain informed consent
                                   must be listed in the CCI application as key personnel in compliance
                                   with CCI/IRB policy. .
                              2.    Protocol.
                              3. Protocol approval letter from the CCI/IRB. .
                              4. Approved informed consents (current as well as previously approved
                              5. All Amendments.
                              6. Amendment approval letter(s) from the CCI/IRB
                              7. Progress Report(s) submitted to CCI/IRB at appropriate time intervals
                                   as determined by the CCI/IRB and/or regulations, not to exceed 365
                              8. Recertification letter(s) from the CCI/IRB
                              9. Materials used in recruiting subjects (e.g., flyers and advertisements).
                              10. All correspondence with CCI/IRB, including emails.

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                              11. All correspondence with sponsor or other outside agencies including
                              12. Copy of all Safety Adverse Event reports (SAE) reports filed with
                                   CCI/IRB, as well as notification to sponsor of the event, if internal.
                                   For an external event, a copy of the sponsor notification of the event
                                   and applicable forms under the CCI/IRB Adverse Event Reporting
                                   Policies. See CCI/IRB Policies found at:
                              13. Enrollment Log (see Appendix A).
                              14. Subject identification code list (kept in separate file with limited
                                   access, i.e. Research Team).
Recommended but not mandatory:
                              15. Delegation of Authority/ Signature Log (see Appendix B)

                   B. Additional Documents required for trials involving biologics, drugs, or
                                              devices Not Under IND, IDE
                               1. Copy of Investigator Brochure, when applicable, or package insert
                                  for marketed drugs.
                               2. In instances when the sponsor of the trial sends drugs or biologics
                                   directly to the Research Team, to be stored outside of Pharmacy and
                                                                  used specifically in the trial, the following
                                        a.        A Pharmacy Waiver approved by CCI/IRB is required to
                                                  store drugs/biologics outside of Pharmacy. The
                                                  accountability procedure is the responsibility of the
                                                  Research Team as designated by the Principal Investigator.
                                        c.    b. Drug Accountability log and shipping documents from the
                                                  sponsor (Appendix C).The drug/biologic must be kept in a
                                                  secure area with limited access and used only with enrolled
                                                  study subjects.

Note: If the drug is prescribed as part of clinical practice and is obtained by prescription filled by
outside pharmacy, then the log and associated documentation are not required.
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                              3.      In instances when the sponsor of the trial sends the device directly
                                        a.        Device Accountability log (see Appendix D): records the
                                                  device used for a specific subject, and also may contain
                                                   other information, such as lot number, expiration dates.
                                                  Shipping documents must also be kept. The devices must
                                                  be kept in a secure area with limited access and used only
                                                  with enrolled study subjects and not the general population.
                                                  The research staff, designated by the Principal Investigator,
                                                  is responsible for maintaining these records.
Note: If the device is in clinical use (on the shelf) the device log and associated documents are
          not required.
                          C. Documents required for trials involving biologics, drugs, or devices that
                                                 ARE under IND or IDE
                           In ADDITION to ALL of the documents listed previously, the following
                           are required:
                                1. Signature pages from the protocol and all amendments signed by PI.
                                2. Investigator Brochure.
                                3. FDA Form 1572-(original).
                                4. Signed and dated CV and medical licenses for all investigators.
                                5. Sponsor Financial Disclosure Statements for PI and all Sub
                                6. Screening Log.
                                7. Delegation of Authority Log.
                                8. Signature Log.
                                9. Lab certificates from all labs used in the study (local or sponsor), as
                                      well as normal values.
                                10. Sponsors may also require CV of the lab Director signed and dated.
                                11. Decoding procedures for blinded trials.
                                12. Monitoring Visit Reports (from sponsor or CRO).
                                13.Adverse Event Logs.

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     **Please note for further information please consult or
     contact the sponsor of the trial for other required documentation
                        D. For protocols that present MORE THAN MINIMAL RISK, the following
                                  elements must be included in a subject’s research file:

                                   1. The original informed consent, signed and dated by the
                                      subject and person obtaining consent (may be kept in a
                                      separate file or folder with all other subject consent forms).

                                   2. At the enrollment visit a note must be written concerning the
                                      informed consent process and should include:
                                          a. Subject number.
                                          b. Protocol name.
                                          c. The purpose, procedures, risks, benefits, and voluntariness
                                              of the study has been explained to the subject and the
                                              subject agrees to participate in the research protocol.
                                          d. Informed consent document:
                                                  i.      Subject is given a copy of the informed
                                                           consent. A signed copy is not required.
                                                  ii.     Hospital policy is followed regarding placement
                                                          of the consent in the hospital/clinic chart.
                                                  iii.    The original signed consent is placed in the
                                                           research file.
                                          e. A note that no study related procedure was performed prior
                                              to obtaining the consent.
                                          f. A note that Subject met all inclusion criteria and that no
                                              exclusion criteria were present.

               *All of the above elements listed can be included in a template format that can be
               used as documentation for all study subjects. (It is advisable that the PI or another
               attending physician researcher, either sign or cosign the enrollment note, thereby
               verifying the subject is appropriate.)

                                      3. Past medical history containing all relevant medical information
                                         and physical exam

                                      4. A progress note should be written at each study visit that
                                           a. What study related procedures were preformed.
                                           b. How the subject tolerated them.
                                           c. Any relevant data that will be collected for study points.

           NOTE: Progress notes, lab reports and procedure reports are source documents that
                 support information written on Case Report Forms (CRFs).

                                      5. Information elicited from the subject as to adverse events or
                                           serious adverse events. This information must be documented
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                                           with specific detail as to date of first occurrence and when the
                                           event concluded. If the subject reports a hospitalization (serious
                                           adverse event), the appropriate source documentation, i.e. health
                                           record, discharge summary when available, should be kept with
                                           the SAE report in the regulatory file. Adverse Event reporting
                                           should be followed to ensure compliance with CCI policies.

                     E. Documents required for trials involving biologics, drugs, or devices that ARE
                                              under IND or IDE
                                           1. Case Report Forms-supplied by the sponsor and generally
                                                kept in a separate binder.
                                           2. Copies of all lab tests, diagnostic test results that were
                                                preformed as part of the protocol or for clinical care

  IV. Corrections to a study file must be made with a single line through the error accompanied
      by initials and date. White Out or erasure is not permitted.

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Appendix A
Enrollment Log

Initials/Age     Date    Inclusion        Exclusion       Enrolled   If not, why ?
                        Criteria Met   Criteria Present
        Appendix B
Delegation of Authority and Signature Log

   Name (print)       Signature             Role in Study   Date From   Date To   Principal Investigator
Appendix C


   Date       Quantity      Date     Subject    Number of      Balance   Dosage given   Initials   Comment
 Received                Dispensed             Vials/tablets
Appendix D
Device:_______________     Size:____________________

   Date      Device      Lot Number   Expiration      Date                                    Comment
 Received    number                     Date       Dispensed   Subject   Balance   Initials

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