Recognizing Common Research Study RecordKeeping Mistakes

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Recognizing Common Research Study Record-Keeping
Mistakes

• Jessica A. Randall, MA
• IRB Compliance Manager
• Weill Cornell Medical College

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Why record keeping? Why Documentation?Why me?

• Federal Regulations Requirement FDA, OHRP, HHS
• Subsequently, Weill Cornell Medical College
  (WCMC) requirements
• FDA Common Rule 1 If its not written downit
  didnt happen.
• Change in Staff Always be in the know
• (i.e. subject follow-up, patient safety issues)
• Audits (internal or external)

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Department of Health Human Services (HHS) on
Documentation

• Code of Federal Regulations excerpt title 46
  Human Subject Protection says An institution, or
  when appropriate an IRB, shall prepare and
  maintain adequate documentation of IRB
  activities, including the following
• Copies of all research proposals reviewed,
  scientific evaluations, if any, that accompany
  the proposals, approved sample consent documents,
  progress reports submitted by investigators, and
  reports of injuries to subjects.
• Records of continuing review activities.
• Copies of all correspondence between the IRB and
  the investigators.
• Statements of significant new findings provided
  to subjects, as required by 46.116(b)(5).
• (a) The records required by this policy shall be
  retained for at least 3 years, and records
  relating to research which is conducted shall be
  retained for at least 3 years after completion of
  the research. All records shall be accessible for
  inspection and copying by authorized
  representatives of the department or agency at
  reasonable times and in a reasonable manner.

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objective

• Learn ways to think more critically about the
  protocols you work on.
• Take in the bigger picture of what is actually
  going on versus what the consent form and
  protocol say is going on.
• When you look at the study always put yourself in
  the position of a new subject on the receiving
  end of all of this paperwork (advertisements,
  the consent form, the HIPAA Authorization form).
  It will really open your eyes.

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Subject Research Record/examples of Source
Documentation

• Name
• Address
• Phone number
• E-mail
• When consent HIPAA Authorization were obtained
  and that the subject was given a copy of each (or
  refused)
• Dates times
• Tests completed
• Follow-up
• The experience
• Questions the subject asked/was concerned about
• Anything else of note (i.e. Subject did not
  complete the eye exam portion of the study as she
  did not want to remove her makeup)

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The Medical record (paper electronic)

• REMEMBER
• The Research Record and the Medical Record
  are 2 different things (but there are gray
  areas!)
• Remember once a consent form or a research study
  document goes into the medical record (paper or
  electronic) anyone who accesses the file can see
  it. Pay attention to what is written in the
  confidentiality section of the consent. (Thats
  why it is call the informed consent)
• i.e. If the consent form states No one other
  than the PI and his research team will have
  access to information related to your
  participation in the study, then research
  documents should not go into the medical record.

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Sample Research Study Monitoring Plan(hand out)
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Consent form documentation Reminder

• The person obtaining consent must be the person
  signing off on the consent form.
• Only individuals listed as Co-Investigators or
  Principal Investigator on the IRB protocol can
  obtain consent from subjects.
• Incorrect A coordinator (who not listed on the
  protocol) goes through the consent form with a
  subject and the PI signs off at a later time.

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Advertisement issues (flier) Research
opportunity! Exercise
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Advertisement issues

• Clip art (dollar sign eyes) not appropriate
• Research Opportunity should be Research Study
• Where are adults when age range is 4-17 y/o?
• Research should always be research study
• Volunteer for biking, running or walking!
• No study goal. What is the purpose of doing
  this?
• Every 4 months for 6 months not possible
• Patient this is a study- use participant or
  subject
• Subjects are compensated not paid
• No contact name, title or location given
• Human Subject Recruitment Guidelines handout

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Contact Information

• Jessica Randall, MA
• Compliance Manager
• Institutional Review Board
• Weill Cornell Medical College
• 212-821-0672
• jar2023_at_med.cornell.edu
• BOX 5, A-131