Site management

Services for Saskatchewan Pharmaceutical Researchers

• Identify potential sponsors for investigator-initiated basic-science or clinical studies
• Provide site-management services to ease the administrative burden for investigators and their study staff
• Facilitate efficient local approvals
• Facilitate contract negotiations (when the University of Saskatchewan is a signatory)
• Support patient recruitment and retention efforts
• Provide educational opportunities for Saskatchewan pharmaceutical researchers and their staff
• Facilitate certification examinations by international credentialing bodies for Saskatchewan research personnel

Site Management Services

SDRI has developed administrative-support, site-management services to assist researchers conducting human clinical trials. 

STUDY-SITE REGULATORY DOCUMENTS
SDRI prepares, collects, and forwards all the necessary study-site regulatory documents to the Sponsor, including, but not limited to: the FDA1572 Form; Health Canada's Qualified Investigator Undertaking Form; current, signed and dated curriculum vitae for the investigator and study staff; current medical license(s); laboratory normal values; accreditation certificates for laboratories and hospitals; research ethics committee rosters; Financial Disclosure Forms; and appropriate protocol signature page(s). 

ETHICS REVIEW COMMITTEE APPLICATIONS
SDRI prepares and submits applications to ethics review committees with the goal of optimizing approval times. 

• Prepare the application form(s), including a study summary, if required
• Review and revise the consent form to meet local requirements
• Make submissions to the required ethics review committee, such as the University of Saskatchewan Biomedical Research Ethics Board
• For the duration of the study, submit all documents requiring ethical review/approval (including, but not limited to protocol amendments, administrative letters, investigational drug brochures, and serious adverse event reports) to the appropriate committee. All approvals and ethics review committee correspondence are forwarded to the Principal Investigator and Sponsor by SDRI

SPONSOR'S CLINICAL TRIAL / FINANCIAL AGREEMENT(S)
When the University of Saskatchewan is a signatory on the agreement(s):

• SDRI conducts an initial review, in order to expedite the University of Saskatchewan review/negotiation process. The focus of this review is to ensure that all required elements are present and worded in accordance with the University's requirements.
• Once finalized, SDRI ensures that the appropriate authorization signatures are obtained

SDRI SITE-MANAGEMENT AGREEMENT
When the University of Saskatchewan is NOT a signatory on the agreement(s): 

• SDRI can provide site-management services, exclusive of clinical trial agreement review, under the SDRI Site-Management Agreement

SERVICE IDENTIFICATION
Prior to starting a study, SDRI will help to identify, in collaboration with the Principal Investigator and the Research Coordinator, the required services (i.e. laboratory, radiology, ECG, etc.). Such services may be provided through a local Health Region or private provider. 

LOCAL HEALTH REGION / PRIVATE SERVICE PROVIDER LIAISON
SDRI will assist the research site in making formal applications for approval of the use of resources, Health Region or private. 

STUDY MEETINGS
In order to provide and maintain high quality services tailored to the needs of each research site, SDRI personnel will attend study meetings, including site assessment, initiation, and multicenter study meetings. 

TRAINING AND QUALITY ASSURANCE
SDRI provides regular educational events designed for investigators and their study staff on current topics relevant to pharmaceutical research. In addition, SDRI can assist in the training of new research staff regarding the fundamentals of Good Clinical Practice and provide ongoing support. 

PATIENT RECRUITMENT
SDRI will assist with the preparation and ethics review committee approval of advertisements or recruitment letters and help to develop other strategies to increase enrollment. 

BUDGET PREPARATION
Upon request, SDRI will assist the Principal Investigators/Research Coordinators in the preparation of a study budget, based on local costs. Final approval of the study budget is the responsibility of the Principal Investigator.

FINANCIAL SERVICES

• All Sites
  SDRI will receive and track payments for work done by sites. Periodically, the SDRI accountant reviews the payments made by Sponsors and ensures that these are current.

• Sites Who Pay U of S Overhead
  SDRI can coordinate the set-up of payroll for research staff, pay study-related expenses, and liaise with the Sponsor and University of Saskatchewan accountants. SDRI will submit to the Principal Investigator a report of account activity, upon request.

STUDY PAYMENTS
In order to increase the efficiency of the management services provided, all study payments must be made payable to:
University of Saskatchewan/Saskatchewan Drug Research Institute.