Data Safety Monitoring Board (DSMB)

Data Safety Monitoring Board (DSMB) Periodic Report Form (PRF)

Protocol Number

DIRECTIONS: Submit this signed and completed form to [email protected] as a single bookmarked PDF with the following documentation in order: (Note: For multi-site trials, the WCM DSMB requires that you submit information representative of all trial sites.) (a) The most up-to-date research protocol. (b) The most up-to-date WCM IRB-approved Non-Technical Research Plan from the WCM IRB Protocol Application (c) Study Design pasted from the protocol. (The hypothesis, research question, standard and experimental procedures, special or unusual equipment of procedures.) Include specifics on all study interventions and their frequency (e.g., administration of study drug, surgical intervention, blood draws, clinical assessments, etc.) i. List together in a group all procedures that are part of standard of care treatment if being administered as part of the research, and list together in a group all procedures that are investigative, separating and labeling the two groups. Tables and/or charts are helpful and encouraged. For randomized studies, provide the above information for each study group. (d) The most up-to-date WCM IRB-approved Risks section of the WCM IRB Protocol Application (e) The most up-to-date WCM IRB-approved Informed Consent Form and assent(s), if applicable. (f) AE Narrative Requirement 1: Narratives (with a heading at the top of the page indicating “AE Narratives” and organized by subject) of any adverse events that have occurred since your last Periodic Report that have resulted in any of the following outcomes: i. Death ii. A life-threatening adverse experience iii. Inpatient hospitalization iv. Prolongation of existing hospitalization v. A persistent or significant disability/incapacity vi. Congenital anomaly/birth defect (g) AE Narrative Requirement 2: Narratives of any adverse events that are important medical events that may not result in death, be life-threatening or require hospitalization, but based on appropriate medical judgment require medical or surgical intervention to manage them. (h) An Adverse Event & IND Safety Reporting Cumulative Table for each study arm. I.e., if there are two study arms there must be two clearly labeled cumulative tables. The table is available at http://weill.cornell.edu/research/research_integrity/institutional_review_board/irb_adv.html. i. If this is a blinded trial and you are submitting unblended data to the DSMB this must be done by a designated third party who can submit this portion to [email protected] separately. (i) If your study is conducted under an Investigational New Drug Application, include all IND Safety Reports since your last submission to the DSMB, including whether the INDs Safety Reports represent events that have occurred before, and including the number of subjects receiving the investigational drug. This information may be obtained from your sponsor. (j) Additional information and interim data as prescribed in your protocol’s unique data safety monitoring plan. (k) Any Immediate Reports made to the WCM DSMB in accordance with the Human Research Protections Program Immediate Reporting Policy at http://weill.cornell.edu/research/research_integrity/institutional_review_board/irb_adv.html.

For assistance in the completion of your submission, email us at [email protected]. You may also call (646) 962-6988 for cancer clinical trials, or (646) 962-4065 for general clinical trials. 1 1. Principal Investigator Phone E-mail

2. Co-Investigator(s)

3. Research Coordinator Phone E-mail

4. Protocol Title

5. Research Site(s)

6. Sponsor(s)

7. Source of Funding

8. Population Being Studied (Check all that apply):

Normal Controls

Elderly

Children (<18 years)

Pregnant women

Psychologically or neurologically impaired

Specify Other:

9. Protocol Status:

Active - No patient enrollment yet. The date the protocol began was: ______(*Proceed to end of form, provide signature and date.)

Active

Active - Closed to patient accrual, but open to follow-up

Terminated Reason for Termination: (*Proceed to end of form, provide signature and date.)

10. Narrative Synopsis – Please provide a narrative synopsis of the research to date. This will allow the DSMB to understand what has occurred in the study thus far.

11. Beneficial Outcomes – If your study has beneficial outcomes, such as a Phase II or III therapeutic evaluation, please summarize beneficial outcomes, presenting data for each arm of the study separately.

2 12. Has there been any change in the protocol since the last report to the DSMB that changes what is done to the subjects?

If yes, please:

A. Detail the changes to the protocol and explain the reason(s) the change was made:

13. Enrollment Charts*

A. Enrollment Summary

Since Start of Protocol Since Last DSMB Report

Enrolled (i.e., signed the consent form)

Screened

Still Receiving the Procedure/Intervention (Type Name of Intervention)

Dropped after Consent was Given

Are in Long-Term Follow-Up

Completed Protocol (I.e., are no longer in long-term follow-up)

*If the protocol is multicenter and/or multi-arm, then you must also complete Table 13B below.

3 B. Enrollment Summary for Multi-Site and/or Multi-Arm Protocols

Site 1 Site 2 Site 3

Arm A Arm B Arm C Arm D Arm E Arm A Arm B Arm C Arm D Arm E Arm A Arm B Arm C Arm D Arm E

Number Enrolled

Screened

Currently receiving treatment/intervention

Subject discontinuation

Long-term follow-up

Completed Protocol

C. Subjects Who Dropped Out After Screening

Subject ID Date Enrolled Date Dropped Out Reason

4 14. Has accrual been proceeding more slowly than expected or is accrual lower than expected? If so, please explain why you believe this to be the case:

15. Additional Information – Please provide any other information that the DSMB should know that was not already mentioned in this form.

16. Signature

PI Signature: ______Date: ______