QI Program Summer Series

1. QI Program Summer Series Most Common Mistakes QI Program Top Ten List MGH August 2, 2007

2. Background Information • Partners QI Program established in June 1999 • The QI Program has reviewed more than 800 studies • 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 occurrence)

3. Top Ten Common Mistakes • Not familiar with Partners policies/requirements • Lack ofwritten documentation of consent process • Incomplete documentation of consent process • Use of invalid consent form • No documentation of subject eligibility • Incomplete source documentation • Lack of proper accountability • Missing essential documents • Failure to utilize study management tools • Failure to recognize protocol deviations

4. Findings: Don’t know where to find information  Listen to others or study sponsor! Actions: Visit PHRC website:http://healthcare.partners.org/phsirb/guidance.htm Know the basics/what applies to your study Know who to call. Plenty of available resources: QI: http://www.partners.org/phsqi/ CRP: http://www.massgeneral.org/crp/ #1 Not Familiar With PHRC Policies and Guidance

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

6. 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 anyresearch related procedures

7. Findings: Subject or study representative did not date or the date is incorrect Subject identification not on all pages Incomplete option sections Actions: Review consent form carefully before subject leaves Check dates, signatures and option sections Place subject ID on all pages Utilize notes to file QI compliance checklist #3 Incomplete Documentation of the Consent Process

8. Findings: Missing IRB approval stamp Expired consent form Invalid consent form Actions: Check for approval stamp Note valid date and expiration dates Follow-up with protocol administrator Utilize Insight Report violations to the HRC #4 Use of Invalid Consent Form

9. 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

10. Findings: No documentation that subject has met all eligibility criteria (e.g. eligibility criteria checklist) Lack of source documentation supporting eligibility Actions: Implement eligibility checklist  Useful template: http://www.partners.org/phsqi/QIWeb/files/Eligibility%20Checklist.doc Obtain and file source documentation Use notes to file if found in an alternate location #5 No Documentation of Subject Eligibility

11. Findings: Blanks, blanks and more blanks! Missing header information ~ no subject identification on documents Actions: Do not leave blanks ~ every space should have an entry Include appropriate subject identifiers Utilize abbreviations N/A, N/D, UNKN Write notes to file #6 Incomplete Source Documentation

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

13. Findings: Documentation not signed and dated by the person obtaining the information Unacceptable correction methods Actions: Sign and date information at the time it is recorded Create forms with places for signatures and dates Use single line cross-out through entry do no obscure original entry (no white out) #7 Lack of Proper Accountability

14. Findings: Essential documents not on file: CVs Licensure Lab certification Investigator Brochure Product Accountability Actions: Maintain a copy of essential documents in the study binder Review ICH GCP at: www.ich.org Check valid/expiration dates; update regularly QI Program study binder:http://www.partners.org/phsqi/vrb/files/index.htm #8 Missing Essential Documents

15. Findings: No study logs in place Enrollment log Staff signature Delegation of responsibility Adverse event Actions: Never too late to get organized  Create and utilize study logs QI Program templates:http://www.partners.org/phsqi/ToolsPage.htm #9 Failure to Utilize Study Management Tools

16. Findings: Non- adherence to the protocol, including informed consent and enrollment Missed study visits Failure to obtain scheduled lab draw Drug dosing errors Blanks on data collection forms = missing data? Actions: Know definitions (exception, deviation, violation) Report in accordance with PHRC policy:http://healthcare.partners.org/phsirb/prodevex.htm Include prevention plan in report Address in source docs Amend protocol as needed #10 Failure to Recognize Protocol Deviations

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

18. 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