DSMC Monitoring Form:Pilot, Phase I And Phase II Trials

Today’s Date:
Protocol Number: / Principal Investigator:
CRA/CRC or Research Nurse:
/ Accrual to date: Target:
Is accrual open? Yes No

FOR ALL TRIALS

  1. Please indicate the anticipated Primary Completion Date from the Clinicaltrials.gov record.
/ Anticipated PCD:
Not registered on Clinicaltrials.gov
  1. Is this an Investigator-SponsoredMulti-center trial being performed outside of DF/HCC?
/ YesNo
If yes, please complete Attachment A.
  1. Since the last review, has the treatment been administered as per protocol?
  1. If No, please explain (or attach explanation):
/ Yes No
  1. Since the last review, did any subjects experience grade 2 or 3 events that were unexpected and related/associated with the intervention?
  1. If Yes, were they reported to the IRB?
1)If, N/A, please explain:
  1. If Yes, were they reported to the Sponsor?
1)If, N/A, please explain:
  1. Please attach grade 2 or higher unexpected toxicity reports submitted to the IRB and Sponsor for subjects on studysince the last review.
  2. Total number of grade 2 or 3 unexpected toxicities related/associated with the study intervention reported to the IRB and Sponsorsince the start of the trial.
/ YesNo
Yes No N/A
Yes No N/A
Mark as attachment 4c
IRB
Sponsor
  1. Since the last review,did any subjects experience grade 4 life–threatening events?
  2. Please attach all grade 4 life-threatening events-unless specifically listed in the protocol as not requiring reporting, since the last review.
  3. Total number of grade 4 events reported to the IRB or Sponsor since the start of the trial.
/ Yes No
Mark as attachment 5a
IRB
Sponsor
  1. Since the last review,was any subject hospitalized for grade 2 or higher, unexpected events that were related/associated with the intervention?
  2. If Yes, were they reported to the IRB?
1)If, N/A, please explain:
  1. If Yes, were they reported to the Sponsor?
1)If, N/A, please explain:
  1. Please attach serious, unexpected toxicity reports submitted to the IRB and Sponsor for hospitalizations on study, since the last review.
/ Yes No
Yes No N/A
Yes No N/A
Mark as attachment 6c
  1. Since the last review,did any subject die?
  1. For all deaths, please attach a brief summary of all deaths and presumed etiology.
/ Yes No
Mark as attachment 7a
  1. Has this protocol been audited by an external entity other than ODQ?
/ Yes No
If Yes, and an Audit Report is available, please submit and mark as attachment 8.
  1. Where is the CRF data maintained?
For DF/HCC Inform trials, attach aMissing Forms Report (MFR) in PDF format. Include the full DSMC report (including the summary of toxicities) from InForm when available. Otherwise, provide the MFR Summary Detail report from OnCore.Report date must be no more than 2 weeks prior to the DSMC form submission deadline. / DF/HCC Inform (CTRIO/ODQ)
Attach MFR as item 9a
Sponsor, please specify:
Other, please explain:

FOR PHASE I TRIALS

  1. Has the correct dose escalation scheme been followed?
/ Yes No N/A
  1. Have there been any DLT’s?
  1. If Yes, please describe (or attach description):
/ Yes No N/A
Mark as attachment 11a.
  1. Has the MTD been reached?
  1. If Yes, what is the MTD?
  2. If No, what is the current dose level?
/ Yes No N/A

FOR PHASE II TRIALS

  1. Are there early stopping rules described in the protocol?
/ Yes No
  1. During this reporting period, were any early stopping rules triggered?
/ Yes No
  1. If early stopping rules were triggered, please describe what protocol required action was taken.
  1. Please describe (or attach description):
/
Mark as attachment 15a.
  1. Did any patients meet the criteria defined in the protocol for response?
  1. Please describe (or attach description):
/ Yes No
Mark as attachment 16a.

ADDITIONAL COMMENTS (or attach separate page):

If someone other than the PI is signing this form, please include your printed name under your signature.

By signing below I certify that the Overall Principal Investigator has reviewed this report.
SIGNATURE______ Date
Prepared by: (please print)______

Attachment A:Investigator-SponsoredMulti-Center Trial Progress Report

Protocol Number: DF/HCC Overall PI & Sponsor:

  1. Informed Consent Document Review:

Sponsor or designee must review each participating site’s consent form for logistics, spelling and consistency. This includes both the initial IRB approved consent as well as any amended versions.

External Site Name / Date of review
  1. MonitoringCompliance:

Please provide monitoring reports previously not provided to the DSMC for each monitoring visit indicated below.

External Site Name / Date(s) of Monitoring / Type of Monitoring
(On-Site or Virtual)

Comments:

  1. Auditing Compliance:

External Site Name / Date(s) of Audit / Audit rating

Comments:

  1. Communication and Training:

Please provide details/minutes of communication to confirm plan is being followed. (i.e. dates of teleconferences with minutes etc).

By signing below, I certify that I as the Overall Principal Investigator have reviewed this report.
SIGNATURE OF OVERALL PI ______Date

Version: April 2018Page 1 of 4