Monthly Centre Web/Teleconference Meetings -2018

Monthly_Centre_Meeting_Summary [June 2018]

Noteworthy Items:

Notices:

  • Welcome to Beren Avci, new OCREB REC;
  • OCREB Stakeholder Survey Results;
  • Timely and efficient way to contact applicable study staff – provide OCREB with a central email address or designated contact;
  • CTO DIER versus OCREB pre-approved changes and controlled honour system for implementation of approved provincial consent form(s).

Reminders:

  • Authorized administrative changes to consent forms;
  • Annotated application forms;
  • Requests for archived O2 files;
  • OCREB training session June 14 @ 10am

Monthly Centre Meeting Summary [May 2018]

Noteworthy Items:

Notices:

  • Selection of short study title – use the sponsor’s study ID when widely known/referenced
  • Approval date – ‘date approval issued’ in the letter, is the approval date
  • Multiple amendments – please combine amendment submissions when feasible and/or contact the REC for more information
  • OCREB training session – contact Aurora for dates in June

Reminders:

  • Amendment summaries/rationale – please include a summary and a rationale in the application
  • Submission of DSMC reports – please submit DSMB/C and interim reports as provincial reportable events (PCR) even if the report is attached to the Provincial Continuing Review (PCR) application
  • Timing of Continuing Review (CR) submissions – as close to the submission deadline as possible
  • Accessing OCREB review letters – located under the history tab

Monthly Centre Meeting Summary [April 2018]

Noteworthy Items:

Notices:

  • April 3 notice to researchers, research teams, institutional reps, sponsors and CROs: NOL and CT registration no longer required for OCREB approval – see What’s New?
  • Consent changes not requiring pre-approval
  • Changes to Section 1 in PAM and CAM take effect immediately
  • More than one Centre PI appearing in PAM approval letters

Reminders:

  • Please check all provincial documents to ensure that spelling, grammar, punctuation and formatting (spaces, footers, etc.) are accurate and appropriate
  • April 3 notice to researchers, research teams, institutional reps, sponsors and CROs – OCREB Controlled Honour System Model for Centre Consents – see What’s New?
  • Contact with participants during the study – request for information
  • Institution-wide email address changes
  • Staffing changes/leaves

Monthly Centre Meeting Summary [March 2018]

Noteworthy Items:

Notices:

  • OCREB REC job posting and upcoming OCREB staff absences
  • Annotated CTO Stream application forms posted
  • Adverse events – cannot be updated once they a submission is acknowledged
  • Requirements for declaring new conflicts of interest or changes to existing conflict of interest declarations
  • Requests for files from OCREB’s previous online system (O2)
  • OCREB adopting CTO Stream letter templates
  • Legacy fields in migrated studies

Reminders:

  • Timing of CR submissions – as close to the submission deadline as possible;
  • PI response letter requirements
  • NOL submission requirement changes

Monthly Centre Meeting Summary [February 2018]

Noteworthy Items:

Notices:

  • Role of Provincial Applicant (PA)
  • Guidance on the use of frequencies for specific risks
  • Centre Continuing Review Application question guidance

Reminders:

  • Timing of Continuing Review (CR) submissions – as close to the submission deadline as possible
  • Document naming and version dates
  • Updated IBs with related consent form changes
  • Providing Study staff with access to studies/centres
  • Initial expiry date now set from the date that all criteria are confirmed as met
  • Accessing archived OCREB membership lists
  • PI response letter requirements
  • NOL submission requirement changes

 

Monthly Centre Meeting Summary [January 2018]

Notices:

Reminders:

  • OCREB mandate requires more than one Ontario participating site. Check with OCREB if unsure.
  • Departing staff  – notify CTO Stream Support so that CTO Stream accounts can be disabled
  • Study Closures: ensure that all centres have closed before submitting a provincial study closure form
  • Translated questionnaires – please include with the PIA when available
  • Urgent communication with the OCREB team – please call or email outside the system
  • CTO Application form tips