Full Board and Expedited Studies
Jacksonville – IRB-03
Please provide contact information for a representative who can answer any questions that the IRB might have concerning this submission:
Name:
Position:
E-mail:
Phone #:
Pager #:
2nd Contact: / name + e-mail or phone number
Group:
o IRB Chair Review – only submissions that are Minimal Risk qualify for IRB Chair Review. IRB-03 strongly recommends submitting your Continuing Review report no later than 3 weeks prior to the expiration date.
o Meeting deadlines – in order to qualify for a selected Meeting your completed submission must be received in the IRB-03 Office by the specified deadline. Only submissions that meet our Acceptability Standards will be considered to have met a deadline. IRB-03 strongly recommends submitting your Continuing Review report before the deadline for two meetings prior to the expiration date. This affords you time to still obtain timely approval if your project requires Explicit Changes, is tabled, or has other issues.
Form Instructions:
· Make sure your Microsoft Word program is set to display “Hidden Text”. This document contains helpful information, examples, and instructions that are only visible (and will never print) when the “Hidden Text” feature is enabled. “Hidden Text” will be displayed highlighted yellow, italics, and underlined. Go to the “Tools” menu, “Options”, on the “View” tab make sure “Hidden Text” has a check mark, and click “OK”. (Word 2007 users can download how to display Hidden Text at: http://irb.ufl.edu/docs/hidden07.doc).
· Submit One signed original plus one electronic copy (Entire Continuing Review Packet) to the IRB-03 office. The electronic copy should be sent via email to . This must include copies of all paperwork including grants, surveys, data collection tools, articles, etc. You should also retain one copy of the submission for your files. You may need to submit copies to other committees/offices.
· Regardless of study status, every Section below must be completed.
· The Report must be signed by the Principal Investigator on the signature line at end of report. Co-PI, sub-I, or other signatures are NOT sufficient unless accompanied by a completed Temporary Transfer of PI Responsibility
· Subjects’ names or other identifying information (medical record numbers, etc.) must not appear in this Report or in any correspondence with the IRB. Use a black marker to block/cover up any identifying information on all copies submitted to the IRB.
· This report must be typed.
· Submissions that do not meet our Submission Acceptability Standards will be returned to the PI. Visit http://irb.ufl.edu/irb01/formsubmit.htm for more information.
Continuing Review Page 1 of 8
IRB version date: 07/25/2011
PI version date:
ALL QUESTIONS MUST BE ANSWERED and
VERSION DATE MUST BE ADDED TO FOOTER
Date:Principal Investigator:
PI UF ID#:
IRB Project #:
Project Title:
1. We wish to continue this study for the following purposes:
We plan to screen and/or enroll additional new subjects.
Enrollment of new subjects is completed (no additional subjects will be screened and/or enrolled). Select one of the answers below:
Study interventions continue on at least one subject. NOTE: You must receive continuing IRB approval to continue study interventions.
All therapeutic interventions are completed on all subjects and all that remains is (a) data collection and/or (b) follow-up as described in the ICF. Describe what activities remain: . NOTE: You must receive continuing IRB approval to conduct these activities. NOTE TO IRB: move to longitudinal review if previously considered a full Board study.
All interventions are completed on all subjects and only statistical analysis of already collected data with identifiers or links to identifiers remains. NOTE: You must receive continuing IRB approval to conduct these activities. NOTE TO IRB: move to longitudinal review if previously considered a full Board study.
All interventions are completed on all subjects and only statistical analysis of already collected data that is now de-identified or no links to identifiers remains. NOTE: You may close the study. If so, you must attach a letter signed by the PI certifying that the data has been de-identified. Refer to Question 1 about funding issues. NOTE TO IRB: if the PI does not close the study you may move it to longitudinal review if previously considered a full Board study.
All interventions, data collection, and data analysis are completed. NOTE: Do not complete this form. Submit Study Closure Report.
You must have active, on-going IRB approval in order to enroll any subjects, perform any study interventions, collect/report new data, and/or analyze identified data. You do not have to continue the approval for your project if you have finished (a) enrolling subjects, (b) performing all study interventions, (c) collecting any data, and (d) analyzing any data with identifiers or links to identifiers. Once you close your study you may only analyze data which (1) was previously collected while your project was approved (note: you may not collect or analyze any new data without IRB approval), AND (2) is de-identified by HIPAA standards prior to the project’s closing. If your project meets these criteria and you need to receive funding once the project is closed, send a letter to Tina Bottini at the Office of Research Affairs signed by the PI certifying that (a) all human subjects research and data collection has been completed, (b) only statistical analysis of previously collected and de-identified data remains, and (c) funding is required to pay salaries, etc. Lastly, you do not have to keep your study open in order for your study sponsor to analyze any data. Remember however that you may not collect or report any new data once your study is closed
2. During this review period, have there been any changes, no matter how minor, to any part of this research project, including the IRB approved forms (Introductory Questionnaire, Protocol, Informed Consent Form, Investigator Brochure, or any other materials reviewed by the IRB)? Examples include, but are not limited to: changes to the study procedures, addition of a subtitle, departure or addition of an investigator, change in funding, change in number of subjects to be enrolled?
No.
Yes. If yes, select one:
All changes implemented to this project have been previously reported to and approved by the IRB.
Changes have been implemented but were not submitted to the IRB.
Explain:
3. Are you submitting any new revisions along with this Continuing Review/Study Closure Report? If the protocol you have attached is different than the one that was last approved by the IRB you must answer this question “Yes” and provide a revision form that details the changes.
No.
Yes. You must include: (1) a Project Revision Form, (2) all altered pages of the Introductory Questionnaire, Protocol, ICF, or other project documents with insertions underlined and deletions struck-out, as well as a clean copy of the pertinent pages.
4. Study sponsor: Is your study sponsored?
No. Skip to Question 5.
Yes. Provide the name(s) of all of your study’s sponsor(s): . and answer a. and b. below.
a. Have there been any changes to the study’s sponsor(s) during the past review period?
No.
Yes.
b. Are the study sponsors correctly listed on the Introductory Questionnaire and all of the Informed Consent Forms for this study?
Yes.
No. You must revise all of your paperwork to correctly identify the study sponsor(s).
5. Have there been any changes in the potential conflict of interest information described in your Introductory Questionnaire for any of the investigators (including the Principal Investigator, Co-PI, and/or Sub-Investigators) associated with this project? For example, have any patents/licenses been applied for or obtained in relation to this project? Have any investigators, their relatives, or companies controlled by any of these individuals obtained stock or stock options in the sponsor or another company related to this project? Have any of the investigators served as a consultant, received honoraria, or other compensation outside of the grant/contract for this project from the sponsor, directly or indirectly? No.
Yes. Describe: .
Have any changes in potential conflict of interest been reported to the Division of Sponsored Research? In particular – have you reported it to the Assistant Director of Compliance, Michael Scian?
No.
Yes. Explain: .
6. External audit: Has the Food and Drug Administration, study sponsor, or any other agency audited this project during this review period? Routine monitoring by the sponsor or their representative (e.g. a contracted CRO) does not constitute an audit unless it generates an official written response from the monitor.
No.
Yes. Have you enclosed reports for all external audits that occurred in the past review period?
Yes.
No. Indicate who audited your study, when all audits occurred, and when the audit reports will be provided to the IRB: .
7. Study results: Have you or any of the local sub-investigators reported any data from your study?
No.
Yes. Date: . Provide a copy of the publication or meeting proceedings.
8. How do you identify and recruit potential subjects?
Under a previously approved HIPAA Waiver of Authorization for Recruitment (review of medical records, databases, part of clinical care).
Other. Describe:
9. Have any subjects been enrolled in this project:
No. Explain why you have not started this project:. Skip to Question 26.
Yes. Check all that apply
Subjects have signed an informed consent form
Study procedures including collecting data from patient medical records were initiated using a waiver of informed consent?
Enter accurate information. You should compare all information entered in this report with what has been previously reported to the Board. If you discover that there are discrepancies with or errors in previously reported information, attach a separate cover letter explaining the differences.
10. Did the IRB waive the requirement to obtain or document Informed Consent (ICF) to enroll all subjects in this study? (Requested in the approved Introductory Questionnaire). Do not answer Yes if all subjects must sign an Informed Consent form.
Yes. How many subjects have you enrolled in this project under your waiver . Skip to Question 16.
No.
11. Provide the date on which the first subject signed the Informed Consent Form (ICF) at this site:
12. Was an Informed Consent Form (ICF) signed by each subject or their legally authorized representative?
Yes.
No. Explain:
13. Did all subjects or their legal representative receive a copy of the ICF?
Yes.
No. Explain:
14. Provide the date on which the last (most recent) subject signed the Informed Consent Form (ICF) at this site:
15. Have you enclosed a copy of the last three signed ICF with subjects’ name blacked-out?(If you have enrolled less than 3 subjects check yes and enclose copies of all signed consents) Investigators are required to submit a copy of the entire Informed Consent Form (ICF) signed by the last subject enrolled at this site (even if this consent has not changed and was submitted to the IRB at a previous Continuing Review). Use a black marker to completely block the name, initials, and signature of the subject anywhere it appears in the form. Do NOT block the date of the subject’s signature. Do not use white-out. Leave the names, signatures, and dates for the PI and the witness (if applicable).
Yes.
No. Explain:
16. How many subjects have been enrolled since the study started?
All subjects who have signed an Informed Consent form are considered enrolled.
If you were approved for a Waiver of Informed Consent to Enroll subjects, include all subjects enrolled under the Waiver.
The total # of subjects should automatically calculate/update when the form prints. If you would like to verify the number before that, right click on the number with your mouse and select “Update Field”.
0 / + / 0 / + / 0 / + / 0 / + / 0 / = / 0Active Subjects / Subjects in Follow Up (for data collection only) / Withdrawn (include deaths) / Screen Failures / Completed Subjects / Total subjects enrolled
Total males enrolled: 0
Total females enrolled: 0 / NOTE: total # of males and females added together must enter the total subjects enrolled above.
17. As indicated above, have any subjects withdrawn from this study?
No.
Yes. Explain why all of these subjects withdrew (by PI, subject, and/or adverse event):
18. As listed in your last approved Introductory Questionnaire (IQ), how many subjects has the IRB approved for enrollment into this project? Federal regulatory agencies consider any subject who signs an informed consent form to be enrolled in the study.
19. Have you enrolled more subjects than currently listed in this project’s last approved Introductory Questionnaire (IQ)?
No.
Yes. Explain why: .
If you enroll more subjects than you are approved for it is considered Regulatory Noncompliance – similar to enrolling subjects on a research study that never received IRB approval. If you have enrolled more subjects than you were approved for you
should attach a separate cover letter explaining how/why this occurred, any potential risks to subjects, and what corrective action steps you are going to take to prevent this from reoccurring in the future.
You should also take this opportunity to assess how many additional subjects you might enroll in the coming year / approval period. If you think you might exceed the total previously approved by the IRB you should consider submitting a revision to increase the total to avoid potential noncompliance.
Either way, you should always verify that you have not exceeded the total number of subjects you have been approved for and can submit a revision at any time to increase the number. Please recognize that if your project involves any risk or needs full Board review that a request to increase the number of subjects should require full Board approval – so you should take meeting deadlines into account.
20. Do you hope to enroll more subjects than currently listed in this project’s last approved Introductory Questionnaire (IQ)?
No.
Yes. Explain why: . You must include: (1) a Project Revision Form, (2) all altered pages of the Introductory Questionnaire, Protocol, ICF, or other project documents with insertions underlined and deletions struck-out, as well as a clean copy of the pertinent pages.