CONTACT INFORMATION. PHRC Office. Josephine O Driscoll-Davis. Michael Ducey

Transcription

1 PHRC Office CONTACT INFORMATION 116 Huntington Ave., 10 th Floor Boston, MA Josephine O Driscoll-Davis Assistant Director Administrative Chair (617) jodriscolldavis@partners.org Michael Ducey Administrative Chair (617) mfducey@partners.org

2 Agenda 1. Why is Continuing Review Necessary 2. Instructions for Preparing and Submitting Continuing Review through eirb/insight 3. Required Information for Continuing Review 3. Amendments/Minor Deviations Tracking Log 4. Amendments/Unanticipated Problems 5. Common Problems Identified at Submission

3 IRB Considerations: Continuing Review Continuing review of research is conducted at intervals appropriate to the degree of risk, but not less than once per year for federally funded and more than minimal risk research (45 CFR (e)). At the time of continuing review, the IRB should ensure that the criteria for IRB approval under HHS regulations at 45 CFR continue to be satisfied. To review any new information that has emerged, either from the research itself or from other sources, that could alter the IRB s previous determinations, particularly with respect to risk to subjects. Review any unanticipated problems that have occurred since the previous IRB review.

4 IRB must determine that: Continuing Review Provisions under the previously approved protocol for monitoring study data to ensure safety of subjects have been implemented and are working as intended. e.g., the IRB could require that the investigator provide a report from the monitoring entity described in the IRB-approved protocol.

5 Preparing Your Continuing Review Application Complete the continuing review Application by logging into Insight at: Instructions are on our website at the attached link: Click to attach with submission the most recently approved versions of the protocol, protocol summary and consent form(s) for re-approval. Please click the clean version; otherwise Insight will pull the document (version) on top for each item attached. Include any previously approved recruitment materials. An Amendment must be submitted to remove any previously approved study documents that are no longer in use.

6 Preparing your CR Application (Continued) Race/Ethnicity Enrollment Report must be consistent with the total enrollment number reflected in Section 5.0 of the Application. Sections 5.1 to 5.10 of the Application must also equal 5.0. The Enrollment Report template is now embedded in the Continuing Review Application Application. A separate Form is no longer required. Include any surveys, questionnaires, etc. that are still being used. Create a list of standard instruments/questionnaires for committee review in addition to attaching each instrument separately.

7 Continuing Review Intake CR Team Intake Process: Submission is compared to what was submitted last year and to most recent approved documents in Insight; Study history checked to ensure that Amendment changes over the past year are reflected in the submitted documents; Check that recruitment materials, letters, postcards, flyers, telephone scripts and any handouts match those that were previously approved; Safety Monitoring Reports: DSMB/DMC/Monitor/Monitoring Group/Coordinating or statistical center (or Adverse Events Tracking Log for PI monitored studies); Check that the Minor Deviations Tracking Log is cumulative and consistent with what has been previously reported and that corrective actions are included.

8 Continuing Review Intake Continued For studies that are PI initiated and qualify under FDAAA and have registered with ClinicalTrials.gov an NCT number is required and a designation letter, when applicable. Also, the CF should contains the standard paragraph to inform subjects that the study is registered with ClinicalTrials.gov If PI is the holder of IND/IDE, the annual report to the FDA is required Check study staff inconsistencies prior to submission and include a Study Staff Amendment if adding or deleting co-i s or study staff. Submit Financial Disclosure Forms when adding individuals with an invested interest in the research, if applicable Please check that CITI training is up-to-date for all current study staff. Study Staff Amendment is required to make changes Submitting a standard Amendment Application at the time of continuing review: Changes to the study documents must be bolded/highlighted (not using color), + clean copies. Attach only revised and clean documents with the Amendment

9 Amendments at Continuing Review Proposed changes to approved research during the period of approval can be reviewed at the time of continuing review: Complete Amendment Application in Insight. Attach any revised documents to the Amendment submission. Check the box indicating that the Amendment should be considered with the Continuing Review. Check the box on the Continuing Review Application to alert PHRC staff that missing documents required for Continuing Review are attached to the Amendment submission. Check all appropriate boxes in the Amendment Form, indicating what aspects of the study are being changed. Complete any fields that are opened after checking the boxes. If Amendment is adding or revising drug/device or radiation procedures ancillary reviews are required: Radiation Safety Pharmacy Biomedical Engineering

10 Unanticipated Problems Continued The continuing review report includes, among other things, a summary of any unanticipated problems and available information regarding adverse events and any recent literature that may be relevant to the research The amount of detail provided in such a summary will vary depending on the type of research being conducted For example, a summary could be a simple brief statement that there have been no unanticipated problems and that adverse events have occurred at the expected frequency and level of severity as documented in the research protocol, the informed consent document, and any investigator brochure The HRC recognizes that local investigators participating in multi-center clinical trials usually are unable to prepare a studywide summary of adverse events for their IRBs because such information is not readily available to them

11 Unanticipated Problems In such circumstances, when the clinical trial is subject to oversight by a monitoring entity (e.g., the research sponsor, a coordinating or statistical center, or a DSMB/DMC), OHRP recommends that at the time of continuing review local investigators submit to their IRBs a current report from the monitoring entity. OHRP further recommends that such reports include the following: A) a statement indicating what information (e.g., study-wide adverse events, interim findings, and any recent literature that may be relevant to the research) was reviewed by the monitoring entity; B) the date of the review; and the monitoring entity s assessment of the information reviewed; C) the conclusion of the group with respect to continuing the research or discussion of changes, if needed

12 Minor Deviations Minor Deviations means any deviation that does not impact subject safety, affect the integrity of the study data and/or affect the subject s willingness to participate in the study For example: Visit outside of study window Lab/procedures (not for safety) questionnaires not completed Data points that do not impact data integrity missed Minor Deviations Tracking Log The cumulative Deviations Tracking Log is available at the PHRC website under Instructions and Forms and should be updated ongoing and submitted at the time of Continuing Review (

13 Expedited Continuing Review Types of Applications: Intervention / Interaction* - research that involves an Intervention / Interaction with human subjects *May not qualify for expedited review Health/Medical Records - research limited to the use of health/medical information derived from patient health/medical records Excess Human Material and Related Health Information - research limited to the use of excess clinical samples/specimens and related health information Secondary Use of Samples/Data - research limited to the secondary use of samples and/or data originally collected for research Research Data Repository research limited to establishment of a repository of health/medical information derived from patient health/medical records for future research use Tissue or Sample Repository - research limited to banking or storing human material/tissue for future research use

14 Expedited Continuing Review Continued You no longer have to choose which application to complete at the time of Continuing Review. Insight will provide you with the continuing review application that is consistent with what you submitted at the time of your last Continuing Review, or Initial Application (if this is the first Continuing Review for your study).

15 Expiration of IRB Approval The date upon which IRB approval expires is printed on the IRB Review Notification Letter; on the Protocol Details page in Insight and in the consent form footer The approval expiration date also displays in Insight/eIRB. You can sort all of your active protocols by the expiration date column Continuing review notices are ed to PI and contact person(s) 90, 60, and 30 days prior to expiration date When IRB approval expires, you cannot do any of the following: No recruitment and enrollment No study procedures No analysis of data Note: If you have subjects whose welfare will be negatively impacted (treatment studies) by stopping the study, contact the IRB immediately for permission to continue them in the research

16 STUDY CLOSEOUT FOR COMPLETED STUDIES OR STUDIES CLOSED PRIOR TO COMPLETION: Continuing review is required to formally close out the study file Complete the appropriate Continuing Review Application in eirb/insight to inform the PHRC of completion of the study or study closure prior to completion. In such cases, submission of the Protocol Summary/Detailed Protocol/Consent(s) is not required but please attach any relevant publications or update the progress section of the application with a detailed summary of the findings or links to include a listing of publications PI Leave of Absence, Sabbatical, or Moving to Another Institution instructions, what is required:

17 Common Problems at Continuing Review Failure to update the correct version of study documents (Detailed Protocol, Protocol Summary, Consent Forms, Recruitment Materials, etc) reflecting changes from initial or continuing review or as a result of prior amendments Missing most recent safety monitoring report or adverse events tracking log. Checking NO instead of YES on the Application under Safety Monitoring when the study is monitored by the PI Misinterpretation of accrual goal and/or number (once subject signs consent, HRC considers them enrolled in the study) Lack of interim report on study progress, findings, data analysis or explanation for unavailability of this information Out-dated information pertaining to funding source Lack of attention to balance of recruitment of minorities or explanation for lack thereof

18 Common Problems at Continuing Review (Continued) Failure to address how potential conflicts of interest might be handled by a PI who is recruiting from his/her own patient population Not completing the Amendment Application correctly when submitting Amendments during the year. As a result, many of the required changes are not reflected in the HRC database. Below are some examples: When making changes like switching from one online tool to another, say Survey Monkey to RedCap, please check off the "questionnaire" field, which gives you access to the Instrument/Questionnaire form Please check the "drug" box for when changes are made to anything about the study drug/administration/dose etc. If you fail to do this, the amendment will NOT be sent automatically to research pharmacy If making changes to the study enrollment, be sure to check "study population" which provides access to the study population boxes, this is where you should input the new proposed numbers. Slow accrual rate, lack of explanation and strategies to increase the pace. Lack of detail pertaining to subjects who were withdrawn from study participation (how they were managed, need for followup, referral, etc.)