Clinical Trial Services

Intake Form

The Clinical Trial Services (CTS) intake is a mandatory process for investigator-initiated regulated clinical trials for which Sunnybrook Research Institute is the regulatory sponsor. CTS is also available for services for non-regulated trials.

STUDY TITLE
Date of Form Completion / YYYY-MMM-DD

Please complete the information below and submit to .

CONTACT INFORMATION
Name / Sunnybrook/SRI email / Contact Phone
Principal Investigator / MD
PhD
PharmD
Other:
Coordinator
Other:
STAGE OF THE STUDY
Study development (prior to grant submission and finalization/writing of study protocol)
Please attach draft protocol (if available) and any other supporting documents
Funding awarded
Please attach protocol or grant application/proposal / Amount awarded:
Co-applicants (if applicable):
Funding Source:
PARTICIPATING CENTRES
Single centre
Multi-centre / Multi-centre
Total number of sites:
International sites: No Yes
If yes, number of international sites:
List centres: If more than 5, please attach a list.
Name / City / Country
STUDY DETAILS
Study Population:
Has the sample size been calculated? No Yes / If yes, estimated sample size:
Study objectives:
Study duration (accrual period plus follow up phase):

Page 1 of 5

Version Date: April 2016

INVESTIGATIONAL PRODUCT (IP) Not Applicable (please continue to #7)
DRUG, BIOLOGIC, OR NATURAL HEALTH PRODUCT (if more than 1, list separately)
Type / DIN or NHP/DIN-HM # / Manufacturer / How will IP be obtained? / Supply Source / Use in the study
1 / Drug
Biologic
Natural Health Product / #: / Name:
Country:
Importation?No Yes / Purchased
Donated / Manufacturer
Wholesaler
Commercial supply
Other: / Dose:
Schedule:
Route:
Study indication:
2 / Drug
Biologic
Natural Health Product / #: / Name:
Country:
Importation? No Yes / Purchased
Donated / Manufacturer
Wholesaler
Commercial supply
Other: / Dose:
Schedule:
Route:
Study indication:
3 / Drug
Biologic
Natural Health Product / #: / Name:
Country:
Importation? No Yes / Purchased
Donated / Manufacturer
Wholesaler
Commercial supply
Other: / Dose:
Schedule:
Route:
Study indication:
4 / Drug
Biologic
Natural Health Product / #: / Name:
Country:
Importation? No Yes / Purchased
Donated / Manufacturer
Wholesaler
Commercial supply
Other: / Dose:
Schedule:
Route:
Study indication:
PLACEBO
Supply source:

Page 1 of 5

Version Date: April 2016

DEVICE
Name:
Manufacturer:
License (if applicable):
Class:
Study indication:
STUDY PERSONNEL
Qualified Investigator (if different from Principal Investigator):
Sub-investigators (Sunnybrook):
Do you have research coordinators/assistants: No Yes
ADDITIONAL INFORMATION
Please provide any additional information or comments that should be considered in the assessment of your study.

For CTS use:

Completed by: / Date (yyyy-mmm-dd):
Comments / Notes:
TO BE COMPLETED BY CTS

List of Services

Date of Form Completion / YYYY-MMM-DD

Investigator-initiated regulated studies, whether single or multi-centre, are required to contract Clinical Trials Services (CTS) for the following mandatory services:

MANDATORY SERVICES FOR SUNNYBROOK INVESTIGATOR-INITIATED REGULATED STUDIES
  • Quality review of protocol

  • Submissions to Health Canada (Clinical Trial Application (CTA) review and approval, CTA-A (Amendments), CTA-N (Notifications), CTSI, SUADR reporting, Investigator Brochure updates, Safety Information updates, Site updates)

  • Trial Master File review and approval

  • Monitoring
-Site Initiation Visit (external sites)
-Interim Monitoring Visit(s) (all sites)
-Close-out Visit (all sites)
  • Archiving (if not already arranged by QI or department

IMPORTANT: For multi-centre regulated clinical trials, project management services through CTS are highly recommended and in large-scale or high risk trials may be mandatory.

CTS is a full-service academic research organization (ARO) that is able to provide additional services at a fee.

OTHER AVAILABLE SERVICES / Check if requested
STUDY DEVELOPMENT
  • Quality review of protocol (for non-regulated trials)

  • Study design consultation

  • Budget development and verification of costs for funding application

PROJECT MANAGEMENT
  • Central office clinical trial coordination services, which includes a Project Manager responsible for (recommended for multi-centre regulated trials):
  • site selection
  • Regulatory application(s) and submissions (including notifications, CTSI, SUSARs)
  • site start-up processes
  • trial registration
  • central trial master file
  • central communications
  • contracts management
  • site monitoring
  • study investigational product management
  • meetings and webinars
  • recruitment strategies
  • site management
  • safety management/reporting plan(AEs/SAEs)
  • education and training of sites
  • data archiving
  • dissemination meetings
  • assistance with manuscript preparation and submission
  • closeout activities

DATA MANAGEMENT
  • Electronic randomization system programming

  • Randomization schemes programming

  • Electronic data management system
OpenClinica
REDcap
  • CRF/eCRF design and programming

  • Logic and range checks programming

  • Systems and programming validation (required if eCRF programming requested)

  • Training on database and electronic data capture system

  • Integration with other data sources

  • Access database development

  • Interim and final analysis (in coordination with statistician)

  • Data transfer (includes data dictionary)

  • Central office data management which includes a Data Manager and Programmer responsible for above listed items in addition to:
  • central contact for data management for all participating sites
  • generates monthly data reports for data quality assurance
  • site training
  • data analysis plan and reports
  • analysis preparation and data cleaning

FINANCE ADMINSTRATION
  • Budget monitoring

  • Monthly fund reconciliation

  • Dissemination of site payments

  • Dissemination of all invoices and reimbursements

  • Grantee statement or financial reports verification

OTHER (To be requested by study team)

For CTS use:

Comments / Notes:

Page 1 of 5

Version Date: April 2016