When conducting clinical trials as MRCT across multiple countries, specific requirements need to be addressed. For Europe, there are three essential pre-trial preparations that must be completed before starting the study.
1. Appointing a DPO (Data Protection Officer)
Under the #GDPR (General Data Protection Regulation), a DPO must be designated to establish procedures for collecting and protecting personal data and to monitor their proper implementation. Think of the DPO as an "inspector" overseeing compliance with GDPR.
DPO Roles:
- Early Phase of the Project:
- Establish procedures for data collection and protection.
- Mid and Late Phases:
- Ensure compliance with data protection procedures and submit annual reports to the relevant authorities.
- At the end of the trial, confirm there are no data protection violations and submit a report alongside the clinical trial closure report.
Tip: Major CROs (e.g., PPD, IQVIA) often collaborate with DPO service providers in Europe. Partnering with such providers can streamline the process of appointing a DPO. A reliable GDPR service provider is MyData-Trust, which facilitates smooth operations.
More details: MyData-Trust
2. Appointing a QP (Qualified Person)
The QP is critical for ensuring that investigational products (IPs) meet European regulatory standards.
Key Points for QP Appointment:
- If the sponsor has a European subsidiary, the manufacturing personnel can be trained and designated as the QP.
- Without a European subsidiary, the sponsor will need to rely on the CRO’s partner QP services, and this must be included in the contract.
Tip: It is more cost-effective to include the QP role and responsibilities in the initial contract with the CRO rather than amending the contract later to add this role.
3. Appointing a Legal Representative
A Legal Representative is mandatory for conducting clinical trials in Europe.
Key Points for Legal Representative Designation:
- If the sponsor has a European subsidiary, it can act as the legal representative.
- If there is no European subsidiary, the sponsor must appoint one of the CRO’s European offices as the legal representative.
Tip: Designating a single legal representative in any one European country is sufficient to cover the entire region.
Additional Considerations for Clinical Trials in Europe
1. IP (Investigational Product) Customs Clearance:
- Challenges:
- If the IP is manufactured outside Europe, customs clearance can be complex and time-consuming.
- IPs manufactured within Europe usually encounter fewer issues.
- Solutions:
- While expensive, utilizing companies like TNT for customs clearance, shipping, and delivery can streamline the process.
- Recommended IP Logistics Providers:
- Marken, Zuellig, Almac, Catalent, among others. Comparing quotes is advisable to find the best option.
2. Implementing IVRS (Interactive Voice Response System):
- Although not mandatory, building an IVRS for drug tracking and automatic dispensing significantly improves the likelihood of clinical trial approval in Europe.
- While you can proceed without it, having an IVRS in place makes the approval process more efficient and straightforward.
3. GDPR Training for Sponsor Project Members:
- All project members involved in clinical trials in Europe must complete GDPR training and possess a certification of completion.
- GDPR training must be renewed annually.
By addressing these key requirements and considerations, sponsors can ensure smoother execution of clinical trials in Europe. Proper preparation not only ensures compliance with regulations but also facilitates efficient operations and approvals.
