Tier Advancement AssessmentCandidate name: Click or tap here to enter text.
Research Operations: Subject DocumentationDate: Click or tap here to enter text.

Candidate testing level: F ☐ S☐ A☐

Mode: QA review

  • Manager/reviewer select protocol for review (if available, choose those w/ DUHS billing): Pro: ______
  • Manager/reviewer, randomly select 3 participant files that are the responsibility of the candidate, handled within the past 3 months.

______

Competency / Fundamental / Skilled / Advanced
Maintain subject level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require DUHS billing. / Maintains subject level documentation with some assistance and oversight. / Maintains subject level documentation independently, withno regulatory issues identified as major. / Maintains subject level documentation independently for complex studies, and with no regulatory issues identified as major. Demonstrates application of knowledge of subject documentation outside of individual job or assigned studies.

CANDIDATE

  • Describe your role in maintaining subject-level documentation for the protocol above.

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  • If you maintain subject-level documentation for protocols you consider more complicated than the one selected, please describe the complexities. Provide the protocol number.

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  • If different from the above, describe your role in assisting others with subject-level documentation for other protocols.

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Advanced Only: Describe any instances where you have demonstrated advanced application of your knowledge and understanding of subject documentation outside of your individual job or assigned studies. Some examples might include:

  • a description of difficult challenges you have met or helped others to address
  • providing mentorship to others outside of your team
  • developing and provided training to others, and/or
  • evidence that you are seen as a go-to resource for several faculty or staff

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REVIEWER CHECKLIST

Indicate results of your review of 3 subject files below. If the information indicated was verified as complete and accurate, select Yes. If the documentation was missing or incomplete, select No and provide details. If the documentation was not reviewed or not applicable, select the appropriate option. Note: A result must be coded for each category.

  1. General documentation practices – Is the documentation
  2. Attributable to the person observing and recording the info

☐ Yes

☐ No (Please describe:Click or tap here to enter text.)

☐ N/A

  1. Legible in ink

☐ Yes

☐ No (Please describe:Click or tap here to enter text.)

☐ N/A

  1. Contemporaneous, in that it is recorded at the time of the observation

☐ Yes

☐ No (Please describe:Click or tap here to enter text.)

☐ N/A

  1. Original, in that the original copies of source documents available.

☐ Yes

☐ No (Please describe:Click or tap here to enter text.)

☐ N/A

  1. Accurate, in that the documentation is correct.

☐ Yes

☐ No (Please describe:Click or tap here to enter text.)

☐ N/A

  1. Eligibility criteria review
  2. Evidence of participant meeting Inclusion/Exclusion criteria available in study file?

☐Yes

☐No

☐ N/A

  1. Consent form and process review
  2. Correct consent version date used?

☐ Yes

☐ No

☐ N/A

  1. Initials on all pages?

☐ Yes

☐ No

☐ N/A

  1. Did anystudy procedures occur prior to consent?

☐ Yes

☐ No

☐ N/A

  1. Documentation of the provision of the NOPP to healthy volunteers?

☐ Yes

☐ No

☐ N/A

  1. Documentation that participant was given copy of the consent form and/or documentation of consent if conducted verbaly?

☐ Yes

☐ No

☐ N/A

  1. Maestro Care review (if applicable)
  2. Consent documented in Maestro Care?

☐ Yes

☐ No

☐ N/A

  1. Duke patient population subject flagged as research participant in Maestro Care?

☐ Yes

☐ No

☐ N/A

  1. Did any study activities occur prior to entry in Maestro Care?

☐ Yes

☐ No

☐ N/A

  1. Participant appropriate associated with all study related research visits in Maestro Care?

☐ Yes

☐ No

☐ N/A

  1. Other comments about subject level documentation:

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Evaluation Level

This documentation demonstrates:

☐ Fundamental Competency

☐ Skilled Competency

☐ Advanced Competency

Reviewer commentsabout candidate’s competency level:Click or tap here to enter text.

Reviewer Name (Print): ______

Reviewer Title (Print): ______

Reviewer Signature:______Date:______

Special committee review

If appropriate, contact OARC to determine if major issues identified in the past year related to the candidate.Click or tap here to enter text.

Committee Member Name (Print): ______

Committee Member Title (Print): ______

Committee Member Signature:______Date:______

Assessment – RO: Subject Documentation- Page1