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QI Program Summer Series

QI Program Summer Series. Record Keeping: Studies in Transition MGH August 16, 2007 BWH August 23, 2007. Case #1. Department funded study has been active for 15 months Staff: PI, Co-Investigator, RA

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QI Program Summer Series

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  1. QI Program Summer Series Record Keeping: Studies in Transition MGH August 16, 2007 BWH August 23, 2007

  2. Case #1 • Department funded study has been active for 15 months • Staff: PI, Co-Investigator, RA • Initial study packet (mailed to subject): 2 consent forms, med rec release form, several questionnaires • Approx 1 week after mailing packet, RA calls subject to administer telephone questionnaire to subject • Upon receipt, RA reviews mailed questionnaires to determine if any further info is needed from Med rec • ‘Study visit’ is conducted annually for 5 years • An electronic CFR is used • HRC history: 3 amendments, no violations/AEs

  3. Case #1:Observations • Regulatory/HRC Documentation • Principal Investigator CV is on file • A staff signature/delegation of responsibility log in on file however the staff is not current • HRC approvals for the following are on file: Initial approval, CR #1, AME #3

  4. Case #1:Observations • Informed Consent • Several consent forms do not have HRC approval stamp • A study representative had not signed or dated several consent forms • No consent form on file for several subjects

  5. Case #1:Observations • Subject files • Initial and annual telephone questionnaires are not on file • Several questionnaires, completed by subjects at home, do not have identification on them • A completed subject questionnaire included a handwritten note stating the subject had been hospitalized due to the illness and was now living in a nursing home.

  6. Case #1:Observations • Subject files • The version of the subject-completed questionnaire was not the same as the HRC approved version. When you compare the two versions, you notice that the one being used includes an additional family history section.

  7. Case #2 • 5-day, inpatient, physiological, data collection protocol. • Exclusion criteria: • Previous hx of alcohol or other substance abuse • Use of psychotropic medications that affect the sleep-wake cycle (sedatives) • Use of SSRIs • Protocol includes the following procedures: • Body temperature recorded every 10 minutes • Subject bed position maintained at a 45º angle • Follow-up phone calls 10 days after active study participation

  8. Case #2:Observations • Subject Eligibility • 3 subjects reported a hx of alcoholism at screening. No documentation on file to clarify why they weren’t excluded and if the PI considered this exclusion criteria as required by the IRB approved protocol. • The majority of the subjects are taking sedative meds and/or SSRIs. The PI told you he chose to include these subjects after study start up.

  9. Case #2:Observations • Data Collection • Time points for temperature collection are not recorded • Data collection records “bed position changed” and/or “angle changed” • There are no records of follow-up phone calls in subjects files

  10. Case #2:Observations • Additional reporting • You note that one subject complained about the bed angle during the inpatient portion of the study • At the 10-day follow up phone call, subject 123 reported falling asleep and having a car accident while driving home from the inpatient portion of the study • During the 10-day follow up for subject 456, the subject reports a manic episode that required a change in the subject’s medication and an inpatient hospital stay

  11. Case #3 • 1 study visit where subjects are assessed for joint flexion by means of active flexion and passive flexion • An appropriate option section is included in consent form to contact subjects in the future • 42 subjects have been enrolled (study is closed to enrollment) • Recent CR approved: protocol summary, detailed protocol, and consent form.

  12. Case #3:Observations • Recruitment • You find 17 “Screening forms” on file. These are for potential subjects that were never enrolled. They contain name, address, tele #, DOB • The Clinic’s schedule of appointments, with patient names and hospital ID #s from several dates in 2005 are on file. These schedules were used for recruitment

  13. Case #3:Observations • Informed Consent • 33 consent forms are found on file • The option section is not complete for 4 subjects

  14. Case #3:Observations • Data Collection • You are told a Co-Investigator, who has finished his fellowship and taken a new job elsewhere, currently has the data for 40 of the subjects • You find 20 “Kaberry-White Questionnaires” on file.

  15. Are you in this situation? Here’s some help! • Tools/Services to use: • Study protocol • QI Self Assessment checklist • QI Informed consent checklist • Deviation tracking log • Insight • Protocol Administrator • QI Program visit or inservice

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