TMU Call Minutes 09/11/2007
Present
Columbia: Audrey Bauzo-Rosario (for visit), Marlene Carlson and Fred Jarskog
Duke: Joe McEvoy, Leslie Yusko
MGH (Harvard): Don Goff
BIDMC (Harvard):
MPRC: Pat Ball, Bob Buchanan, Ilene Verovsky, and Chris Wells
NIMH: Adam Haim, Mi Hillefors, and Joanne Severe
NKI: Rosemary Coslit, Dan Javitt, and Connie Shope
UCLA: Bob Kern, Stephen Marder, and Ayala Ofek
Wash. U.: John Csernansky, Meaghan Flatley, Emily Thomason, and Pamela Voss
Action Items
Merck
q Do not delay a patient’s consenting because of wait time for ophthalmologist’s appointments. Go ahead and finish consenting patient and schedule eye exam as soon as possible.
q Make sure a Registration CRF has been filled out for a subject as soon as they sign consent. This information is crucial for the reporting system at NKI.
q Focus on signing as many TURNs consents as possible for the report on 09/25!
Allon
q (Rich Keefe) – Prep for “Smell Test” training talk on next Coordinators call.
q (Pat Ball) – Change adverse event reporting procedures to be consistent with Merck
q (Pat Ball) – Revise Physician’s Study Orders to include all medication types.
q (All Sites) – Please review the instructions for canister use.
q (Ilene Verovsky/Lee Bougie) – Determine study drug allotment for sites (12-weeks or entire study allotment).
Avera
q (Don Goff) – Send response concerning FDA hold to IRB.
Biovalve
q Nothing to report
All Protocols
q Nothing to report
Site Monitoring Visit
q Nothing to report
Notes
Merck
q IRB approval status updates (See spreadsheet for updates).
q There have not been any instances of subjects failing because of NPSY testing or symptom criteria.
· Wash U
§ Has a subject that tested + on a Tox screen
§ Subject was tested on 09/11 and will be retested in 30 days (10/30?)
§ Subject claims to not use regularly
q Drug use/abuse
· Concern is with confounding NPSY results
· SCID should be reviewed during screening
· If use occurs during study or within 30 days of beginning
§ Subject should be notified of potential concerns involved
§ Re-test for Tox screen should be administered after 30 days of initial use
§ If subject fails re-screen, they should be excluded/withdrawn from the study
q Screening vs Evaluation
· The “Screening” phase is the term officially used for the first week of the study. This week occurs in between the day the subject signs consent and the day the subject begins the Evaluation phase.
· The “Evaluation” phase occurs during the two weeks the subject is being monitored while taking the placebo and is administered the NPSY and ERP tests.
§ This is equivalent to the “Stabilization” phase in Allon.
q Steve’s meeting with NIMH (Ellen Stover, Jane Goodman and More!)
· 15-20 subjects should be consented by end of September.
· If this schedule is kept we should be able to meet expected time-line.
q Drug dispensation/recovery
· Emergency meds should be returned every week (especially important for return of placebo).
Allon
q IRB approval status updates (See spreadsheet for updates).
q Med accountability was removed from week two of the stabilization phase.
q Manual Review
· Smell ID test
§ Description on p.11
§ Rich will discuss training at next Coordinators call.
· Nasal Exam
§ CRFs for both subjective and objective tests
§ Sorry, no fancy headlamps will be distributed for the study.
· SAE processes
§ Will be reported to Dan Javitt
§ Any SAEs and “unexpected” AEs and should be reported to Dan and Pat.
· Drug Dispensation (Section 8)
§ Drug will be dispensed from Maryland
§ Subjects will be randomized to one of four medication arms
§ High dosage participants will run out of medication in their first can in ~6days. At that point they will switch to their second can.
§ Instructions for canister use can be found in the manual (please review)
§ Drugs will be dispensed after Physician orders have been sent to Ilene at Maryland.
§ Emergency will not be distributed because there should be excess medication in each canister.
· Small dosage canister can potentially last four weeks
· Large dosage subject will have two canisters
§ Storage protocol found in back of manual
§ First dose should be administered on site
· If someone other than subject will be administering the drug, they should be present for this first application
· Subject should also be taught how to prime the canisters
· Please ensure subject is comfortable with the drug application process!
· Ancillary Medication
§ Different lists for each study
· Sample logs and labels are found in the back of the manual
Avera
q Don Goff dispersed FDA hold letter last week.
· IRB would like to hear a response from Avera.
· Avera has not sent out this response yet.
· Don will send out response on 09/14 whether or not Avera follows through with their response.
All Protocols
q All studies should remember to enter data for any repeated assessments (EKG, Urinalysis, etc.)
Site Monitoring Visit
q Nothing to report
Next Coordinators call: September 18, 2007
Next TMU call: September 25, 2007