Quality improvement and human subjects protection program
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Quality Improvement and Human Subjects Protection Program. Delia Wolf, MD, MSCI Pat Moran, RN Colleen McFarland, MSCI Julie Kaberry, MHP. Quality Improvement Top Ten List. Findings and Corrective Actions Don’t let these happen to you -- Easy to fix and even easier to avoid!!.

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Quality Improvement and Human Subjects Protection Program

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Quality Improvementand Human Subjects Protection Program

Delia Wolf, MD, MSCI

Pat Moran, RN

Colleen McFarland, MSCI

Julie Kaberry, MHP


Quality ImprovementTop Ten List

Findings and Corrective Actions

Don’t let these happen to you --

Easy to fix and even easier to avoid!!


Quality Improvement Top Ten List

10. Record Keeping


Record Keeping

  • Binder for regulatory documents

  • An industry sponsored study will require more regulatory documents


Record Keeping(continued)

  • Binder for HRC correspondence with labeled sections for --

    • Protocol (date versions)

    • Investigator brochure or device manual

    • General Correspondence

    • Logs & Qualifications (signature log & CVs)

    • Lab Documentation


Record Keeping(continued)

  • A study file should be kept for each subject -

  • Original signed consent form

  • Inclusion/exclusion criteria checklist

  • Adequate source documents to corroborate entries on CRFs

  • Any correspondence, phone calls, appointment info regarding subject


Quality Improvement Top Ten List

9. Protocol deviations, violations & waivers

10. Record Keeping


Deviations, Violations& Waivers

  • Report any deviations, violations & waivers to the IRB

  • If a deviation, violation or waiver is submitted to a sponsor, it also needs to be submitted to the IRB for approval


Quality Improvement Top Ten List

9. Protocol deviations, violations & waivers

10. Record Keeping

8.Consent Form Issues


Consent Form Issues

  • The latest version is not being used

  • Check approval and expiration dates on consent form

Approval Date

Expiration Date


Consent Form Issues

IRB Initial Approval

Subject Population: ___Adults

IRB Protocol Number: 2000p-000000

Consent Form Approval Date: November 1, 2000

IRB Expiration Date: November 1, 2001


Consent Form Issues

IRB Approval -- Continuing Review

Subject Population: ___Adults

IRB Protocol Number: 2000p-000000

Consent Form Approval Date: October 10, 2001

IRB Expiration Date: October 10, 2002


Consent Form Issues(continued)

  • Subject identifier is missing from pages

  • Subject identifier must appear

  • on the top of all pages of the

  • consent form


Consent Form Issues(continued)

  • Did the subject receive a copy of the signed consent form?

  • Document the fact that

  • subject received a signed

  • copy of the consent form

Informed

Consent


Consent Form Issues(continued)

  • Did the subject date

  • the signed consent form?

  • Never backdate a consent form

  • If subject failed to date the consent form, write a note-to-file


Consent Form Issues(continued)

Did the subject receive a copy of the signed consent form?

If mailed, send 2 copies & document


Consent Form Issues(continued)

  • IRB approval stamp is not on bottom of the consent form

IRB Approval


Consent Form Issues(continued)

Hand written changes can not be made to an approved consent form


Quality Improvement Top Ten List

8. Consent Form Issues

9. Protocol deviations, violations & waivers

10. Record Keeping

7. Eligibility Criteria Checklist


ELIGIBILITY CHECKLIST

  • Partners Investigator’s Responsibilities #3

    • ICH GCP


Quality Improvement Top Ten List

7. Eligibility Criteria Checklist

8. Consent Form Issues

9. Protocol deviations, violations & waivers

10. Record Keeping

6. Study Logs


STUDY LOGS

  • Enrollment Log

  • Staff Signature Log

  • Delegation of Responsibility Log

  • Monitoring Log

  • Drug Dispensing/Accountability Log


Enrollment Log

  • Subject initials and/or study number

  • Gender, ethnicity, date of birth

  • Date of consent

  • Subject receipt of signed copy of consent form

  • Date of screening

  • Reason for exclusion (if applicable)


Staff Signature Log

  • Print name

  • Signature

  • Initials

  • Number 0-9


Delegation of Responsibility Log

  • Trial related duties

  • PI must sign & date


Monitoring Log

  • Date of review

  • Name(s) of reviewer

  • Findings requiring corrective action

  • Meeting minutes


  • Protocol identifier

  • Subject identifiers (initials/study number)

  • Randomization and/or kit number

  • Date dispensed & amount dispensed

  • Date returned & amount returned

  • Initials of person dispensing/receiving

Drug Accountability/Dispensing Log


Quality Improvement Top Ten List

6. Study Logs

7. Eligibility Criteria Checklist

8. Consent Form Issues

9. Protocol deviations, violations & waivers

10. Record Keeping

5. Curriculum Vitae (CVs)


CURRICULUM VITAE (CVs)

  • Sign & date

  • Update (~2 years)

  • ICH GCP

Education

Training

Experience


Quality Improvement Top Ten List

5. Curriculum Vitae (CVs)

6. Study Logs

7. Eligibility Criteria Checklist

8. Consent Form Issues

9. Protocol deviations, violations & waivers

10. Record Keeping

4. NIH Progress Report/DSMB


NIH Progress Report & DSMB Report

Failure to submit a copy of the NIH PROGRESS REPORT and DSMB REPORT to the HRC at continuing review


Quality Improvement Top Ten List

4. NIH Progress Report/DSMB

5. Curriculum Vitae (CVs)

6. Study Logs

7. Eligibility Criteria Checklist

8. Consent Form Issues

9. Protocol deviations, violations & waivers

10. Record Keeping

3. Investigator Brochure


Investigator Brochure

Copy of the INVESTIGATOR BROCHURE (IB) not on file


Investigator Brochure

Why is the IB not on file?

Reason #1:It’s too big to keep in the regulatory binder

Solution #1:Write a signed and dated note-to-file indicating where it is located.


Investigator Brochure

Why is the IB not on file?

Reason #2:We’re studying a marketed drug.

Solution #2:Obtain a copy of the package insert.


Investigator Brochure

Why is the IB not on file?

Reason #3:There is no investigator brochure and the product is not approved.

Solution #3:Obtain a copy of any product information available (e.g. published data)


Investigator Brochure

Why is the IB not on file?

Reason #4:This is a device study.

Solution #4:Obtain a copy of the device manual or any product information available


Investigator Brochure

Why do I need a copy of the IB?

To provide safety and efficacy data from pre-clinical and clinical trials to support human exposure by the route, at the dosages, for the duration, and in the population to be studied.


Quality Improvement Top Ten List

3. Investigator Brochure

4. NIH Progress Report/DSMB

5. Curriculum Vitae (CVs)

6. Study Logs

7. Eligibility Criteria Checklist

8. Consent Form Issues

9. Protocol deviations, violations & waivers

10. Record Keeping

2. Lab Documentation


Laboratory Documentation

  • Not on file or incomplete

  • Missing:

    • Lab Director’s CV

    • Normal Values

    • Certification (e.g. CLIA, CAP)


Laboratory Documentation

Why are lab documents not on file?

Reason #1:Using the same lab for multiple studies.

Solution #1:Write a signed and dated note-to-file indicating where it is located.


Laboratory Documentation

Why are lab documents not on file?

Reason #2:Using the hospital lab.

Solution #2:If not an IND study, N/A If an IND study, obtain a copy of lab documentation.


Laboratory Documentation

Why are lab documents not on file?

Reason #3:The sponsor didn’t provide them.

Solution #3:Request a copy of the lab documentation from all labs being used.


Laboratory Documentation

Why do I need lab documentation?

To document the competence of the facility to perform the required tests, and to support the reliability of data.


Quality Improvement Top Ten List

2. Lab Documentation

3. Investigator Brochure

4. NIH Progress Report/DSMB

5. Curriculum Vitae (CVs)

6. Study Logs

7. Eligibility Criteria Checklist

8. Consent Form Issues

9. Protocol deviations, violations & waivers

10. Record Keeping

1. Source Documentation


Source Documents

  • Inadequate

  • Not signed and dated

  • Pencil used

  • Cross outs not initialed and dated

  • Don’t exist


Source Documents

Q.What are source documents?

A.It’s wherever data is first recorded (original records or certified copies)


Source Documents

Source documents include:

1.hospital records

2.lab notes

3.memos

4.subject diaries

5.evaluation checklists

6.pharmacy dispensing records


Source Documents

7.X-rays

8.copies of transcriptions certified after verification as being accurate and complete

9.microfiches

10.photographic negatives

11.microfilm or magnetic media

12.recorded data from automated instruments


Source Documents

Q.Why are source documents needed?

A.To document the existence of the subject and substantiate integrity of trial data collected.


Quality Improvement Top Ten List

1. Source Documentation

2. Lab Documentation

3. Investigator Brochure

4. NIH Progress Report/DSMB

5. Curriculum Vitae (CVs)

6. Study Logs

7. Eligibility Criteria Checklist

8. Consent Form Issues

9. Protocol deviations, violations & waivers

10. Record Keeping


Partners Quality Improvement and

Human Subjects Protection Program (QI Program)

offers “QI RoundAbout”

What is a

QI RoundAbout?

Call Pat Moran at 726-5146 or email us at [email protected] We will be happy to answer any questions, discuss topics and set up an agenda for a QI RoundAbout at your site.

How can we arrange

a QI RoundAbout?


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