Annual Review Protocol Status Report

Answer each question as completely as possible. If an answer to any question cannot be provided, provide an explanation for the missing answer.

Protocol ID #:	Current Protocol Version:

Study Title:

ENROLLMENT INFORMATION

Overall Study Accrual Target according to protocol:

Overall Total # participants enrolled to date:

Local accrual target (if multicenter study):

Total # Local participants enrolled to date(if multicenter study):

# of local participants currently receiving study intervention:

# of local participants who completed study intervention:

# of local participants currently in follow-up:

# of local participants terminated early or who have chosen to withdraw from the study:

Describe specific reasons for withdrawals or terminations and how many participants each:

How is overall study recruitment progressing compared to the intended schedule? If concerns exist, what is the plan to address them?

How is recruitment in racial and ethnic categories progressing compared to intended schedule?

If concerns exist, what is the plan to address them?

Research Status

(Check the appropriate box below to indicate the status of your study.)

☐ The study is currently open to accrual

☐ The study has been Suspended

Suspension Date:

Describe reason for Suspension:

☐ The study has permanently closed to accrual.	Closure to Accrual Date:

☐ Some participants are still receiving study intervention.

☐ Some participants are currently in the follow-up phase.

☐ Data is still being collected and/or analyzed.

☐The study sponsor has not given permission to close study at our site.

OTHER STUDY INFORMATION

(Include new relevant information that has become available since the last continuing review approval, or initial review approval if this is the first review for continuation)

Have any findings from this study been presented or published other than to a Data Safety Monitoring Board?

☐ Yes	☐ No	If yes, attach the presentation or publication(s)

To the PI’s knowledge, has any publication or relevant information relating to the participants’ risk and benefits on this study become available? This would include any new information about the drugs or procedures used in this study, as well as any new information on alternative therapies for the condition being studied.

☐ Yes	☐ No	If yes, attach the publication(s) or relevant information

Have there been any changes in the research activity, revisions, amendments, or any editorial or administrative updates to the protocol, model consent form, or study participant questionnaires since the last review?

☐ Yes	☐ No

If yes, please list all changes, revisions, amendments, and/or editorial or administrative updates since the last continuing review approval or initial review approval if this is the first review for continuation. Include the respective Protocol Version Dates or Update Dates.

Have the financial conflict of interest disclosures of the PI or any persons listed on the protocol who are involved in the development or coordination of the study changed?

☐ Yes	☐ No	If yes, new Conflict of Interest Statement must be included.

ADVERSE EVENT AND UNANTICIPATED PROBLEM INFORMATION

(Include new relevant information that has become available since the last continuing review approval, or initial review approval if this is the first review for continuation)

Date of last DSMB or Safety monitoring meeting (month/year) How is the study monitored for safety?

☐ Data and Safety Monitoring Board (DSMB)

☐ Safety Monitoring Committee

☐ Not applicable / Other, explain:

If no DSMB or safety monitoring committee is being used, state when and how the continued progress of the study was last monitored/reviewed and state results from that discussion

Number of local participants reporting AEs:

Have there been any incidents, experiences, participant complaints, or outcomes that indicate participants or others may be at greater risk of harm (physical or otherwise) than previously anticipated?

☐ Yes	☐ No

Have there been any unanticipated problems?

☐ Yes	☐ No

If yes to either question above, please provide a description of the unanticipated problem and any corrective action plan implemented.

CERTIFICATION BY PRINCIPLE INVESTIGATOR

I certify that the information provided entirely and accurately describes the current status the research protocol. I request approval to continue with this research protocol.

Name:

Department:	Phone:

Email:

Signature: