Contractual Arrangements
Collaboration Agreements with industry partners with prioritised assets will be put into place with University of Birmingham (Sponsor). The University will enter into separate agreements with associated third-parties. This includes, but is not limited to:
- Chief Investigator
- National Coordinating Centres
- Participating UK Centres
- Vendors providing clinical trial services
- Other academic collaborators for adjunctive scientific studies
- Other industry partners with prioritised assets
There will be two agreements made with the industry partners: a start-up agreement and a main collaboration agreement.
The start-up agreement and associated budget will include all start-up activity costs associated with the initial work-up in preparation for inclusion of the asset into the trial and should be executed rapidly with any amendments restricted to administrative changes only.
The main Collaboration Agreement between the parties will be negotiated once the start-up agreement is finalised. A commitment to execute both agreements in an expedited fashion is imperative to ensure the smooth running of the trial. A videoconference every two weeks between the legal teams of the Sponsor and industry partner will be scheduled following acceptance of an asset into the trial.
Quality Management
The CRCTU holds an extensive Quality Management System covering all aspects of clinical trial management from design through to study closure and archiving.
Data Management
Data will be entered directly by participating centres into a 21 CFR Part 11 compliant electronic Data Capture (EDC) system. Data management will be conducted by the CRCTU.
Country and Site Management
The CRCTU has a well-established network of paediatric centres across the globe with the expertise to deliver complex, early phase trials in oncology. As Sponsor, University of Birmingham (UoB) delegates all country-specific activities to a National Coordinating Centre (NCC) in each country. This is a lead institution that is delegated some of the Sponsor responsibility for the trial within the respective country. NCCs are responsible for obtaining and maintaining regulatory approvals within the country, identifying sites, and managing the trial conduct. As Sponsor, the UoB through the CRCTU, will retain oversight of the conduct of NCCs. UK centres will be managed directly by CRCTU.
CRCTU Requirements
To manage the study efficiently, the CRCTU will require the following information, including any future updates, where applicable:
- Investigator’s Brochure
- IMP Dossier or cross-referral letter
- Details of supply, labelling and manufacture of the asset
- Accepted safety information/language relating to the asset