QUALITY ASSURANCE PROGRAM

PRE-SITE VISIT CHECKLIST FOR RESEARCHERS

The purpose of the Quality Assurance Pre-Site Visit Checklist is to assistinvestigators and research team members in preparing for a routine Quality Assurance Program (QAP) visit. For questions or additional assistance, please contact the Research Department at 563-421-7957 or . The following areas will be reviewed during a routine QAP visit.

Research Personnel

The purpose of this section is to ensure all individuals working on a research study have:

Been approved by the Genesis IRB

Completed the required research trainings

Provided the Research Department with documentation of training completion

All individuals involved in the design, implementation, analysis and/or reporting of a study must have been approved by the Genesis IRB, and must have completed the following trainings:

  1. NIH Protecting Human Subjects Training, or equivalent (e.g., CITI training)
  2. Conflicts of Interest Disclosure
  3. Conflicts of Interest (COI) in Research Training (for certain government-funded studies only)

Use the table below to track all study personnel and their training

LIST OF CURRENT STUDY PERSONNEL / NIH / COI Disclosure / COI
Training / Certificate Sent to
Research

Add lines, if needed

  1. Have all of the personnel (listed in the table above) been submitted and approved by the Genesis IRB?

Yes No N/A

  1. If not, what personnel need to be approved by the Genesis IRB?

NOTE: If personnel need to be added, an amendment will need to be submitted in IRBNet.

  1. Are there any personnel that have been approved by the Genesis IRB that are no longer working on the study?

NOTE: If personnel need to be removed, an amendment will need to be submitted in IRBNet.

Yes No N/A

  1. Have the training records (i.e., certificates of completion) been sent to the Research Department for each person on the research team?

If not, please send the records to

Yes No N/A

Informed Consent Documentation

This section is only applicable for studies that are obtaining informed consent from patients.

Study is obtaining informed consent – follow the questions below

Study is NOT obtaining informed consent – skip to Protocol Compliance section

The purpose of this section is to ensure appropriate informed consent procedures are being implemented and documented.

  1. At the QAP visit, we will ask you to tell us about your participant consenting process. Do you complete the following required activities?

Conduct the informed consent process in a private, comfortable setting

Introduce and describe the study to the participant

Provide the participant with the informed consent form and HIPAA consent

Provide the participant with adequate time to review the informed consent and HIPAA consent

Answer questions about the study

Obtain signatures on the informed consent and HIPAA consent documents

  1. Who consents participants for the study? Is this an appropriate person to perform the informed consent process? (e.g., approved by the IRB, completed IRB trainings, no conflicts of interest)

Yes No N/A

  1. Are you using the current IRB approved/stamped informed consent and HIPAA consent (if HIPAA consent is separate)?

Yes No N/A

  1. Is the signed informed consent and HIPAA consent in each participant’s research record?

Yes No N/A

  1. Is the signed informed consent and HIPAA consent in each participant’s medical record, if the participant is also a patient?

Yes No N/A

  1. Are the informed consent and HIPAA consent (if a separate document):

Signed by the patient and/or legally authorized representative with the date & time of consent

Signed by the person obtaining consent with the date & time of consent

  1. If the study is enrolling children <18, are the parent informed consent and HIPAA consent (if a separate document):

Signed by the parent(s) and/or legally authorized representative with the date & time of consent

Signed by the person obtaining consent with the date & time of consent

Not applicable

  1. If the study is enrolling children <18 and a child assent is required, is the child assent:

Signed/marked by the child with the date & time of consent

Signed by the person obtaining assent with the date & time of consent

Not applicable

  1. If the study is using additional consent documents (e.g., optional labs, biospecimens), are the informed consents:

Signed by the patient and/or legally authorized representative with the date & time of consent

Signed by the person obtaining consent with the date & time of consent

Not applicable

  1. Was a copy of the informed consent and HIPAA consent given to each participant or legally authorized representative?

Yes No N/A

  1. Is the consent process documented in the research record (e.g., documentation patient met inclusion/exclusion criteria, patient was given a consent form, patient was explained the study and questions were answered)? RECOMMENDED PRACTICE, NOT REQUIRED

Yes No N/A

  1. Was informed consent obtained prior to study procedures and/or screening, as applicable, for each participant?

Yes No N/A

Protocol Compliance

The purpose of this section is to ensure appropriate participants are being enrolled in the research study, only approved data is being collected, and participant information is being kept confidential.

  1. Does each participant meet the study inclusion/exclusion criteria, as stated in the IRB approved protocol?

Yes No N/A

  1. Are you collecting only data that was outlined in the IRB approved study protocol? (and no additional data)

Yes No N/A

  1. Are you following the IRB approved process for maintaining study subject confidentiality for this study, as outlined in your IRB approved protocol?

Yes No N/A

  1. Is the patient data being coded according to your IRB approved study protocol, if applicable?

Yes No N/A

IF YOU ANSWER “NO” TO ANY OF THESE QUESTIONS AND ARE UNSURE OF WHAT TO DO NEXT, CONTACT THE RESEARCH DEPARTMENT AT 563-421-7957 OR