CT-Documents and Agreements
The following CT SOP Agreements, Information Routines and Delegation of Tasks contains detailed information about the documents and agreements needed.
It is important to clarify the delegation of tasks in the study and this must be formalised in accordance with the institutions guidelines and procedures.
Avtale med forskningsstøtte (Norwegian). Different hospitals offer different levels of research support. Each health region can offer monitoring and data management. Some may provide statistical support, help with local authority applications etc. Contact your local hospital and/or regional hospital to find out more about the level of support you can expect.
If the monitor is not employed at the sponsor institution, the sponsor should ensure a Data Processing Agreement for Monitoring Services is signed.
Service agreements are made following local hospital routines.
Agreement Multicentre Trial is for agreements between sponsoring institution and participating study sites. A list describing roles and tasks is highly recommended. Contact local research support.
In international trials, the sponsor should ensure the sites can comply with the protocol requirements and that their country specific requirements can be met. Feasibility Questionnaire Template is recommended used. Points to consider are summarised in Working Instruction for International Trials.
For studies receiing support from e.g. pharmaceutiacl industry, the template Agreement for Support from External/Commercial Support may be used, if the company does not have their own template they wish to use.
To ensure that the regulatory safety requirement in other countries can be met, Safety Reporting Specifics should be used.
If the pharmacy you are working with does not have their own agreement template please use the following Samarbeidsavtale apotek (Norwegian) og Økonomisk avtale apotek (Norwegian).
For studies where some tasks are transferred to local hospitals without them being set up as separate sites, a special agreement, Agreement Transfer Of Clinical Trial Tasks between Hospitals should be prepared together with Signature log.
Trial personnel should be informed that their personal data such as name and CV will be archived to comply with regulations and other purposes if applicable, see Privacy Notice for Clinical Trials Staff.