Preparing for Clinical Trials - Key Measures to Ensure Effective Planning

This article aims to provide an overview of the measures that should be implemented to ensure effective planning before the launch of new trials. Most of the requirements apply to both investigator-initiated and industry-sponsored trials and should be incorporated into the daily routines of all trial sites.

Necessary Documentation

A crucial part of the preparation process is gathering all relevant documentation:

Updated CVs and Valid Certificates

It is recommended to create a shared folder where all key personnel, including the principal investigator, sub-investigators, study nurses/study coordinators, and other relevant staff, have up-to-date CVs and valid Good Clinical Practice (GCP) certificates. A list of approved GCP courses can be found on the NorCRIN website: GCP courses provided by NorCRIN partners(Norwegian). Most sponsors require that GCP certificates be no older than two years.

In some cases, study nurses or study coordinators, in addition to laboratory personnel, are required to hold valid certificates for handling and transporting biological material, such as the IATA certificate. This certificate must be renewed annually.

Accredited Laboratories

In addition to IATA certification, it is also beneficial to have documentation of the accreditation of medical laboratories. Accreditation ensures that the laboratory processing biological materials has the necessary validation and calibration documentation available, such as calibration certificates and temperature logs. Accreditation is an official confirmation that services are performed in accordance with an international standard. An overview of accredited laboratories can be found at Norwegian Accreditation.

Information on Electronic Medical Record Systems

During the planning phase of a clinical trial, information about the hospital’s electronic medical record system - often referred to as the Assessment of electronic systems at site level - is frequently requested. It is useful to have a designated contact person familiar with the technical details and approval processes related to the system.

Agreements and Contracts

Agreements and trial contracts between the sponsor and the investigational site are coordinated by an internal hospital unit or an external technology transfer office (TTO). The trial site is responsible for internal agreements, which include contracts with departments necessary to conduct trial-specific procedures, such as laboratory services, medical imaging, and pathology.

Facilities and Medical Equipment

Hospitals should have routines and procedures in place for facilities, including premises, storage space, and technical equipment. Clinical trials typically require physical storage space for lab kits, equipment, and confidential/sensitive documents.

All clinical trials require some degree of paper-based archiving, which must be securely managed, e.g., in lockable cabinets with controlled access. These cabinets should be easily accessible to both trial personnel and monitors.

The necessary equipment for conducting clinical trials varies, but in general, there should be access to scales, height measuring devices, blood pressure monitors, ECG machines, refrigerators and freezers with temperature monitoring, and centrifuges. Sponsors often require documentation of equipment calibration and maintenance.

Efficient Organisation

Preparing for a new trial is time-consuming, but the process becomes easier with well-established routines. Trial sites should establish efficient procedures and ensure that the necessary expertise, documentation, and infrastructure are in place, enabling them to quickly take on new trials.

To avoid unnecessary delays, sponsors should be provided with the correct contact persons and delivery addresses as early as possible in the start-up process. A complete checklist (Word) can be downloaded from the NorCRIN website.

Insurance for Trial Participants

For clinical trials involving medicinal products, it is the sponsor’s responsibility to secure clinical trial insurance in accordance with the Product Liability Act (Produktansvarsloven). Trial participants are also covered under the Patient Injury Compensation Act (Pasientskadeloven).

NorTrials Can Help

The NorTrials coordinating unit is available to assist in the preparation process. Feel free to contact one of our advisors with any questions or challenges at: contactnortrials@ous-hf.no.

The article was translated from Norwegian to English using ChatGPT and edited by Ellen Johnsen.