Project management services (non-exhaustive list)
- Support for the confidentiality agreement (CDA) and the internal and external feasibility process
- Planning and handling of the selection visit
- Submission of the study for evaluation of institutional suitability (CHUM)
- Drafting and/or revising consent forms
- Negotiation of budgets and establishment of service agreements with the CHUM
- Liaising with stakeholders (study sponsor, contracts office, CHUM services and departments, etc.)
- Correspondence with the research ethics committee throughout the duration of the project (initial evaluation, amendments, SAE/SUSAR/AESI/DLT, annual renewal, etc.);
- Planning and management of study sponsor visits (initiation, monitoring, closure) Support for security reports, information reports and requests for clarifications (queries)
- Data management
- Closure and archiving of the project
When the project is initiated by a CHUM researcher (sponsor-investigator), the following services are also offered:
Project startup and management
- Feasibility assessment
- Management of clinical trial applications to Health Canada (submission, amendments, letters of clarification, etc.)
- Review of the research protocol and associated documents
- Drafting consent forms and manuals (e.g. laboratory, pharmacy)
- Development of a recruitment plan
- When the project involves multiple centres:
- Selection of participating centres
- Budget negotiation with the selected centres
- Planning of the selection visit
Monitoring
- Implementation of a monitoring plan
- Review, distribution and management of SAE/SUSAR/AESI/DLT
- Management and planning of monitoring visits
- Communications management (e.g. conference calls, newsletters, monitoring reports)
- Support during inspections by a regulatory agency
- Closing visit
Clinical services (non-exhaustive list)
- Anthropometric measurements (e.g. height, weight, body surface area, body mass index).
- Diagnostic tests (e.g. electrocardiogram, respiratory physiology tests: spirometry/DLCO to assess diffusing capacity of the lungs for carbon monoxide)
- Measurement of vital signs (e.g. blood pressure, saturation, pulse, temperature, heart and respiratory rate)
- Nursing care (care techniques such as blood draws, intensive PKs, specimen collection centres, administration of study medication, opening of a Port-a-Cath or PAC and physical examination)
- Nursing care (data collection such as medical history, concomitant medications, adverse effects, etc.)
- Support for a protocol visit (e.g. treatment visit with intensive PKs, treatments with oncolytic viruses or innovative treatments, complex visit)
Laboratory services (sample management)
- Management of laboratory kits (assembly, ordering, storage, inventory)
- Processing of samples according to protocol
- Sending of samples to various external laboratories for analysis
- Drafting of the laboratory manual
- Coverage of blood tests not offered by the CHUM (e.g. cytokine dosage, complement C3, C4, CH50 dosage, etc.)
- Collection, processing and storage of samples and management of associated clinical data as part of a biobank project