Procedure Consent Form Template - PowerPoint by mme89049


More Info
									QI Program Summer Series

   Most Common Mistakes
   QI Program Top Ten List

     MGH August 2, 2007
         Background Information
 Partners QI Program established in June 1999
 The QI Program has reviewed more than 800
 Top 10 findings are primarily from QI routine on-
  site reviews
 Top 10 findings are those ten deficiencies most
  commonly found (not in order of the frequency of

      Top Ten Common Mistakes
1. Not familiar with Partners policies/requirements
2. Lack of written documentation of consent process
3. Incomplete documentation of consent process
4. Use of invalid consent form
5. No documentation of subject eligibility
6. Incomplete source documentation
7. Lack of proper accountability
8. Missing essential documents
9. Failure to utilize study management tools
10.Failure to recognize protocol deviations           3
          #1 Not Familiar With
        PHRC Policies and Guidance
Findings:                       Actions:
   Don’t know where to find       Visit PHRC website:
    information 

   Listen to others or study      Know the basics/what
    sponsor!                        applies to your study
                                   Know who to call.
                                    Plenty of available

        #2 Lack of Written Documentation
             of the Consent Process
Findings:                       Actions:
   No written notification        Incorporate notes
    beyond the consent form         regarding consent process
                                    in medical record,
       Did subject receive a       progress notes, note to
        copy?                       file
       Were questions             Develop template

Documentation of Informed Consent
Sample Notations:
•The subject was given a copy of the signed and
dated consent form on (insert date) by (insert staff)
•Study “x” was discussed, and contents of the
consent form were explained. All questions (if any)
were answered to the subject’s satisfaction
•Subject agreed to participate and provided written
informed consent prior to the conduct of any
research related procedures
        #3 Incomplete Documentation of
              the Consent Process
                                    Review consent form
   Subject or study                 carefully before subject
    representative did not           leaves
    date or the date is                 Check dates, signatures
    incorrect                            and option sections
   Subject identification not      Place subject ID on all
    on all pages                     pages
   Incomplete option               Utilize notes to file
    sections                        QI compliance checklist

      #4 Use of Invalid Consent Form

Findings:                  Actions:
   Missing IRB approval      Check for approval stamp
    stamp                     Note valid date and
                               expiration dates
   Expired consent form
                              Follow-up with protocol
   Invalid consent form       administrator
                              Utilize Insight
                              Report violations to the

    Documentation of Informed Consent

                        IRB Approval Stamp
IRB reviewed and approved the study on November 1, 2006
Subject Population: Adults under going xxx procedure
IRB Protocol Number: 2006p-123456
Consent Form Valid Date: November 3, 2006
IRB Expiration Date: November 1, 2007

An amendment to change the consent form was approved on March 2, 2007
Subject Population: Adults under going xxx procedure
IRB Protocol Number: 2006p-123456
Consent Form Valid Date: March 2, 2007
IRB Expiration Date: November 1, 2007
               #5 No Documentation of
                  Subject Eligibility
Findings:                        Actions:
   No documentation that           Implement eligibility
    subject has met all              checklist 
    eligibility criteria (e.g.          Useful template:
    eligibility criteria                 b/files/Eligibility%20Checklist.doc
    checklist)                      Obtain and file source
   Lack of source                   documentation
    documentation                       Use notes to file if
    supporting eligibility               found in an alternate

    #6 Incomplete Source Documentation

Findings:                      Actions:
   Blanks, blanks and more       Do not leave blanks ~
    blanks!                        every space should have
   Missing header                 an entry
    information ~ no subject      Include appropriate
    identification on              subject identifiers
    documents                     Utilize abbreviations
                                      N/A, N/D, UNKN
                                  Write notes to file
            Source Documents

Source Document - first place study data are
recorded. All information in original records
necessary for the reconstruction and evaluation of
the trial.
            - Hospital records/medical records
            - Lab reports
            - Subject diaries
            - Standard assessments
            - Diagnostic tests (x-rays, MRI, CT)     12
       #7 Lack of Proper Accountability

Findings:                     Actions:
   Documentation not            Sign and date
    signed and dated by the       information at the time it
    person obtaining the          is recorded
    information                      Create forms with places
   Unacceptable correction           for signatures and dates
    methods                          Use single line cross-out
                                      through entry
                                     do no obscure original
                                      entry (no white out)

         #8 Missing Essential Documents

Findings:                        Actions:
   Essential documents not         Maintain a copy of
    on file:                         essential documents in
       CVs                          the study binder
       Licensure                   Review ICH GCP at:
       Lab certification
       Investigator Brochure       Check valid/expiration
                                     dates; update regularly
       Product Accountability
                                    QI Program study binder:

            #9 Failure to Utilize Study
               Management Tools
Findings:                    Actions:
   No study logs in place      Never too late to get
     Enrollment log             organized 
     Staff signature           Create and utilize study
     Delegation of              logs
      responsibility            QI Program templates:
     Adverse event              htm

        #10 Failure to Recognize Protocol
Findings:                       Actions:
   Non- adherence to the          Know definitions
    protocol, including             (exception, deviation,
    informed consent and            violation)
    enrollment                     Report in accordance
       Missed study visits         with PHRC policy:
       Failure to obtain           evex.htm
        scheduled lab draw         Include prevention plan
       Drug dosing errors          in report
   Blanks on data collection      Address in source docs
    forms = missing data?
                                   Amend protocol as
                Top Ten Tips

1. Review Partners policies/requirements
2. Get to know the QI Program and other useful
3. Never be afraid to ask!
4. Get organized as soon as possible
5. Ensure all members of the research team are
   educated in research compliance on an
   ongoing basis
               Top Ten Tips

6. Know your protocol
7. Document, document, document!
8. Notes to file are your best friend
9. Utilize templates and logs
10. Conduct regular internal reviews


To top