Monthly Centre Meetings -2018

Monthly Centre Meeting Summary [December 2018]

Notices:

‘New’ OCREB Withdrawal Template: Sample Guidance for Documenting Participant Withdrawal,
Updates to annotated PIA,
OCREB staffing changes.

Reminders

OCREB office holiday hours (closed noon December 24, 2018 to January 1, 2019, inclusive),
New ICF template projected release date in early 2019.

Noteworthy Items

The Office for Human Research Protections (OHRP): draft guidance: https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-activities-deemed-not-be-research-public-health-surveillance/index.html.
CTTI: new recommendations proposing a new approach for investigator qualification.
ACRP: ACRP Developing Competence Standards for PIs; Research Projects Show Credentialed Principal Investigators and CRCs Perform Better
FDA: Proposed Rule on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations web site
OICR: Portal to access world’s largest database of pediatric genomic data goes live
CBC: When scientists want their data fudged and why you should care
Outsourcing Pharm: Watchdog files lawsuit against FDA to revamp informed consent, citing 150 deaths
Time: Researchers Want Cancer Patients To Share Their Medical Information In Search of Cures

Monthly_Centre_Meeting_Summary_[November 2018]

Notices

Tuesday December 11, 2018 deadline for the January 11, 2019 meeting,
OCREB office holiday hours (closed noon December 24, 2018 to January 1, 2019, inclusive),
CTO project owner transfers, access to currently approved documents,
Accessing currently approved/acknowledged documents in CTO Stream,
PIA question (1.12) re scientific review.

Reminders

Documentation by study staff when a participant withdraws;
Document naming guidelines,
Timing of new ICF template.

Noteworthy Items

International standards for clinical trial registries: WHO ICTRP Standards document(PDF)
Center Watch: Sponsors Who Don’t Report Trial Data Face Fines
New York Times: Congratulations. Your Study Went Nowhere.
GIZMODO: Your Genetic Testing Results Can Change—Here’s Why
STAT News: With big-name backing, a start-up launches to match cancer patients with clinical trials
Health & Science: Should I worry about radiation exposure from X-rays, mammograms and other scans?
JAMA: Public Attitudes About Clinical Research and Patient Experiences With Clinical Trials.

Monthly_Centre_Meeting_Summary [October 2018]

Notices

OCREB Adopts N2/CAREB SOPs
Year in Review. Tour of OCREB Annual Report 2017-18

Reminders

Transferring Provincial Applicant Role
Notify CTO Stream Support when staff leave to prevent unauthorized access
Requests for documents from O2
OCREB Membership Changes – updated list October 1, 2018
List of active studies/study-centres – updated report September 26, 2018
New studies submitted for the October 12 meeting
Continuing Review applications due by October 23 for the November 9 meeting

Noteworthy Items

Health Canada change to the timing of REB approval of Medical Device Testing Authorizations
New York Times: Top Cancer Researcher Fails to Disclose Corporate Financial Ties in Major Research Journals
Guardian: One top oncologist failed to disclose payments from big pharma
New York Times: Sloan Kettering’s Cozy Deal with Start-Up Ignites a New Uproar
CISCRP Video about Better Health RV: travelling Clinical Trial education

Monthly_Centre_Meeting_Summary_[September 2018 ]

Notices:

OCREB Annual Report for 2017-18 now available online at https://ocreb.ca;
New National Consent Form Template;
Coming Soon! OCREB to adopt N2/CAREB REB SOPs;
Withdrawal of CGSB REB Standard;
Submission of DSMB/C Reports;
PI unable to sign application;
NRG Audit Findings.

Reminders:

Amendments and meeting deadlines, and Continuing Review Reminders;
OCREB controlled honour system for consent forms and recent Memo;
OCREB membership changes – updated August, 2018;
List of studies and study centres – updated September 4, 2018;
New studies submitted for the July, August and September meetings;
Continuing review applications due by September 25 for the October meeting.

Noteworthy Items:

The Atlantic. When Genetic Diseases Threaten Patient Privacy Do children have a right to their parents’ medical information?
US OHRP informational videos for research participants: Informational videos for research participants
US OHRP revised Common Rule videos: Revised Common Rule videos
Global Alliance for Genomics & Health: Maintaining public trust in use of Big Data for Health Science.
General Data Protection Regulation (GDPR). Nature Journal – Science needs clarity on Europe’s data-protection law

Monthly_Centre_Meeting_Summary [June 2018]

Noteworthy Items:

Sex and gender in research: new video for peer review of research – cihr-irsc.gc.ca/e/49347.html; www.cihr-irsc.gc.ca/e/50833.html;
Update: NIH opens nationwide enrollment for precision medicine initiative;
NIH’s Francis Collins on gene-editing, a missed calling, and what he’d change about science – Interview with NIH’s Francis Collins on Gene-Editing;
May 10, 2018 N2 CITI News – release of ICH E6 R2-GCP updated Good Clinical Practice (GCP) Basic Course;
Health Canada Notice May 11, 2018: implementing the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2);
John’s biotechnology firm takes regulator to court.

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:

Including pregnant women in clinical research: Draft FDA guidance; JCB online seminar
humanitarian health ethics (hhe) research group
Nature article: Demand cancer drugs that truly help patients
Delay in implementation requirements of the revised Common Rule

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:

TCPS2: Comments on proposed changes to research involving human cells and cell lines
CTO annual conference March 27-28 and March 26 workshop

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:

Guidance for HC Part C Division 5; and Initiative to Streamline Clinical Trials (ISCT)
Revised Common Rule implementation delayed 6 months
Educational Resources for TCPS 2 for public/participant
CISCRP communicating trial results
Payment and Reimbursement to Research Subjects – FDA Information Sheet
HHS Announces New Conscience and Religious Freedom Division

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:

New OCREB Vice-Chair (second Vice-Chair)
Publication: Pediatric oncology clinical trial participation where the geography is vast: development of a clinical research system for tertiary and satellite centers in Ontario, Canada
OCREB Website Changes – all documents from O2 Home moved to https://ocreb.ca
O2 to be taken offline January 15, 2018
CTO Stream issues
CTO Observational forms – consult with OCREB before using

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