POST APPROVAL MONITORING CHECKLIST: Social Behavioral Research
NUMBER / DATE / PAGE
HRP-430 / 4/18/2017 / 4 of 5
The purpose of this checklist is to allow investigators to conduct a quality improvement self-assessment of their research study and is indicative of what the NU IRB compliance team would expect to see when performing on site monitoring or auditing of your research study.
Instructions: Please complete the section(s) of this checklist that apply to your study. You may print and handwrite answers or you can complete this form electronically. The study file (where you keep all the documents related to your study) should be centralized and can be maintained within an electronic format (saved pdfs and word/excel documents) or within a binder (printed paper copies stored in a three ring binder). If your answers to the questions are "no" please to provide a brief description in the comments area of each section. Additionally, if "n/a" is indicated and you feel that further explanation is needed, please address them in the comments area found in each section. Please email if you have any questions.
Social Behavioral Research
Principal Investigator
STU Number
Research Study Title
Sponsor / Funding Agency (if any)
Study Enrollment Status (check one) / ☐ No participants enrolled
☐ Currently enrolling participants
☐ Closed to enrollment
☐ Long term follow-up
☐ Data analysis
Number of Enrolled Participants
Number of Withdrawn Participants
Name of Person Completing Checklist
Date Completed
1 Regulatory Documentation: Please indicate whether the PI has the following documentation on file; electronic documentation is acceptable. eIRB+ does not serve as an electronic version of your study file.
☐ Yes ☐ No ☐ N/A / Grant
☐ Yes ☐ No ☐ N/A / Annual progress reports for grant
☐ Yes ☐ No ☐ N/A / Correspondence to and from the funding entity
☐ Yes ☐ No ☐ N/A / Signed agreements/contracts between parties. (Examples may include; sub-contracts for an NIH grant, consulting contracts, IRB Authorization agreements, confidentiality agreements, etc.)
☐ Yes ☐ No ☐ N/A / Most recent version of the IRB approved protocol
☐ Yes ☐ No ☐ N/A / Previously IRB approved versions of the protocol
☐ Yes ☐ No ☐ N/A / Most recent version of the IRB approved consent document
☐ Yes ☐ No ☐ N/A / Previous versions of the IRB approved consent document
☐ Yes ☐ No ☐ N/A / Current IRB approved recruitment materials
☐ Yes ☐ No ☐ N/A / Previous versions of IRB approved recruitment materials
☐ Yes ☐ No ☐ N/A / Records of investigator and staff human participants training
☐ Yes ☐ No ☐ N/A / Delegation of authority log (details research staff responsibilities and length of time on study) is on file
☐ Yes ☐ No ☐ N/A / CVs or other relevant documents evidencing qualifications of PI, co-investigators, and all study personnel
Section 1
Additional Comments
2 IRB Documentation on File: Please indicate whether the PI has the following documentation on file.
☐ Yes ☐ No ☐ N/A / Initial IRB approval letter
☐ Yes ☐ No ☐ N/A / All continuing review approval letters Total on file:
☐ Yes ☐ No ☐ N/A / All modification and revision approval letters Total on file:
☐ Yes ☐ No ☐ N/A / All reportable new information acknowledgement letters (previously called “Safety/Other” reports)
Total on file:
☐ Yes ☐ No ☐ N/A / Interim findings (this includes reports back to the sponsor and/or any articles you have published or others have published in relation to this study topic)
☐ Yes ☐ No ☐ N/A / For studies that underwent full board review, notifications of IRB disapproval, deferral, modifications required to secure approval and the Investigator responses are retained within the study file
☐ Yes ☐ No ☐ N/A / Responses to IRB notifications (e.g., disapproval, deferral, modifications required)
☐ Yes ☐ No ☐ N/A / IRB suspensions or terminations
☐ Yes ☐ No ☐ N/A / Copies of email correspondence with the IRB
☐ Yes ☐ No ☐ N/A / If international research, the proposal was also reviewed and approved within the country’s ethics review/approval infrastructure.
Section 2
Additional Comments
3 Protocol Adherence: Please indicate whether the procedures listed below are followed.
☐ Yes ☐ No ☐ N/A / Study procedures are followed as outlined in the current IRB approved protocol
☐ Yes ☐ No ☐ N/A / No significant changes were made to the protocol without first obtaining IRB approval
☐ Yes ☐ No ☐ N/A / If changes were made prior to obtaining approval (for example, to immediately decrease risks to participants), those changes were reported to the IRB
☐ Yes ☐ No ☐ N/A / If deception is used, participants are fully debriefed after all research procedures
☐ Yes ☐ No ☐ N/A / Data sharing (for example, uploading data to a repository like Redcap or as part of a federally funded project is required for this study.
☐ Yes ☐ No ☐ N/A / Data has been shared per the data sharing agreement found in either the protocol or the grant.
Section 3
Additional Comments
4 Document Retention: Please indicate whether the PI has the following documentation on file; electronic documentation is acceptable.
☐ Yes ☐ No ☐ N/A / Consent documents and study files are retained pursuant to University record retention policy
http://policies.northwestern.edu/docs/RUR_Appendix_A031815.pdf
☐ Yes ☐ No ☐ N/A / Records for sponsored research are retained until the sponsor authorizes destruction of the records.
Section 4
Additional Comments
5 Participant Recruitment Procedures: Please elaborate below if the answers below are no.
☐ Yes ☐ No ☐ N/A / IRB approved recruitment methods are being followed
☐ Yes ☐ No ☐ N/A / All recruitment materials (advertisements, flyers, recruitment script, etc.) are IRB approved
Section 5
Additional Comments
6 Participant Selection Procedures: Please indicate whether the procedures below are followed (elaborate if the response is no).
☐ Yes ☐ No ☐ N/A / Mechanisms are in place to verify that each participant meets inclusion/exclusion criteria
☐ Yes ☐ No ☐ N/A / In cases of withdrawn participants, the reasons for participant withdrawal are recorded.
Section 6
Additional Comments
7 Informed Consent Process: Please indicate the type(s) of consent used for this study (more than one may apply):
☐ Written Consent Form ☐ Verbal Consent ☐ Online Consent Form ☐ Waiver of Consent
☐ Parental Consent and Child Assent ☐ Foreign Language Consent
Please indicate whether the following procedures are being followed with respect to the informed consent process.
☐ Yes ☐ No ☐ N/A / Consent obtained before participant begins any research procedures
☐ Yes ☐ No ☐ N/A / Participant or the representative is provided sufficient time to consider whether or not to participate.
☐ Yes ☐ No ☐ N/A / Efforts have been made to minimize the possibility of coercion or undue influence
☐ Yes ☐ No ☐ N/A / The information given to the participant or the representative is in language understandable to the participant or the representative
☐ Yes ☐ No ☐ N/A / Provisions have been made for participants who speak languages other than English. An approved translated consent is provided to non-English speaking participants
☐ Yes ☐ No ☐ N/A / Consent text does not include exculpatory language, in which the participant or the representative is made to waive or appear to waive any of the participant’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence
For the following sections, please complete those that apply to the type(s) of consent selected above:
(Some studies have different stages and methodologies where the same people are consented to different parts of the study using different consents. Please tally the number enrolled with each consent type, some participants may be counted twice.)
Written Informed Consent
☐ Yes ☐ No ☐ N/A / A copy of the signed and dated consent document is offered to the participant
☐ Yes ☐ No ☐ N/A / Documentation that participants were consented to the study with a valid consent form (check IRB watermarked approval at the top of the consent form)
☐ Yes ☐ No ☐ N/A / Documentation of participants who were re-consented and the reason for re-consent
Number of participants enrolled with Written Consent:
Verbal Consent
☐ Yes ☐ No ☐ N/A / An IRB approved verbal consent script is being used to obtain verbal consent
☐ Yes ☐ No ☐ N/A / Information about the study is made available to participants
☐ Yes ☐ No ☐ N/A / Investigator is able to confirm when enrolled participants agreed to participate in the study
Number of participants enrolled with Verbal Consent:
Online Consent Form
☐ Yes ☐ No ☐ N/A / Participant is offered the ability to print the consent form or emailed to them
☐ Yes ☐ No ☐ N/A / Investigator is able to confirm when enrolled participants agreed to participate in the study (does not apply to anonymous studies)
Number of participants enrolled with Online Consent:
Waiver of Consent
☐ Yes ☐ No ☐ N/A / The waiver of consent is still required to conduct the research study
Number of participants enrolled with Waiver of Consent:
Parental Consent and Child Assent
☐ Yes ☐ No ☐ N/A / There is a parental consent form signed for each child participant (select n/a if a waiver of parental consent has been granted)
☐ Yes ☐ No ☐ N/A / There is documentation of child assent for each participant (select n/a if waiver of child assent has been granted)
Number of parents consented: / Number of children assented:
Foreign Language Consent
☐ Yes ☐ No ☐ N/A / The translated consent form was approved by the IRB.
Number of participants enrolled with a foreign language consent:
Section 7
Additional Comments
Instructions: Please complete a copy of this page for ten percent of the participants enrolled. If the answer is “no” or “not applicable”, please justify by typing or writing in additional information as needed.
Participant File
Principal Investigator
Research Study Title
Participant ID
Type of Consent(s) Obtained
Version Number or STU Number
Name of Person Completing Checklist
Date Completed
1 Participant Information
☐ Yes ☐ No ☐ N/A / Participant met inclusion/exclusion criteria
☐ Yes ☐ No ☐ N/A / Participant completed all study related activities in accordance as outlined in the consent process.
☐ Yes ☐ No ☐ N/A / Compensation was dispensed to this participant per the protocol
☐ Yes ☐ No ☐ N/A / All prompt reporting requirements have been fulfilled
https://irb.northwestern.edu/process/reportable-new-information
2 Written Consent - if n/a check here and move to the next section ☐
☐ Yes ☐ No ☐ N/A / Participant provided consent prior to starting any research procedures
☐ Yes ☐ No ☐ N/A / Original signed consent form(s) or electronic documentation of consent are on file
☐ Yes ☐ No ☐ N/A / Consent form is signed on or after the IRB approval date and before the expiration date
☐ Yes ☐ No ☐ N/A / There is an IRB approved watermark or stamp on the consent form
☐ Yes ☐ No ☐ N/A / Consent form is completed in entirety with printed name, signature and date of both the participant and person obtaining consent
☐ Yes ☐ No ☐ N/A / All pages of the consent form are on file for each participant
☐ Yes ☐ No ☐ N/A / All yes/no or similar optional elements on the consent form are completed/initialed. If not, then please explain in the comments section.
☐ Yes ☐ No ☐ N/A / Consent form is free of any handwritten changes/corrections
☐ Yes ☐ No ☐ N/A / The participant signed his/her own consent form (exceptions: IRB-approved surrogate or parental consent)
☐ Yes ☐ No ☐ N/A / The participant was offered a copy of the signed and dated consent form
3 Waiver of Documentation of Consent (Verbal and Online Consent) – if n/a check here and move to the next section ☐
☐ Yes ☐ No ☐ N/A / Research team is able to confirm participant agreed to participate in the study
4 Data Collection
☐ Yes ☐ No ☐ N/A / Data is available for this participant
☐ Yes ☐ No ☐ N/A / For paper data collection tools, changes/cross-outs, additional comments (if any) in participant files are initialed and dated
☐ Yes ☐ No ☐ N/A / For any changes/cross-outs being made, the original entry is still legible (e.g. use of white-out or pencil erased entries is not acceptable)
☐ Yes ☐ No ☐ N/A / Data is collected and maintained in accordance with the IRB approved protocol
General Comments