Structure of a Clinical Investigation Plan

Even the smallest scientific endeavour needs to be considered in advance so that possible good or even very good results can be understood by others and evaluated as meaningful. This applies equally to observational studies as well as randomised controlled trials, clinical investigations (medical device clinical trial) or performance study (diganostic medical device clinical trial). Errors in the preparation can no longer be corrected later or will at least be very expensive.

Creating a clinical investigation plan is a complex task that must take many aspects into account. From study design to data collection and reporting, each step requires precise planning and care and must be strictly aligned with the right question for the product being tested.

On the way to the perfect clinical investigation plan: Step by step to a successful clinical study

In accordance with Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR), the Medical Device Law Implementation Act (MPDG), ISO 14155:2020 and the guidelines of the Medical Device Coordination Group (MDCG), the following elements are taken into account when preparing a clinical investigation plan (CIP) for a scientific study in the field of clinical research with medical devices:

Structure and contents of a clinical investigation plan for the generation of evidence for medical devices

1. general information

• Introduction and background: a general introduction to the study, including the CIP reference number, a summary of the review history and an overview of the clinical study.
• Contact information: details of key stakeholders including sponsor, legally designated representative and principal investigator.

2. rationale and objectives

• Rationale of the study: Rationale for conducting the clinical investigation, including the scientific and clinical reasons.
• Objectives of the study: Clear definition of the primary and secondary objectives of the clinical study.

3. design and methodology

• Study design: Description of the study design, including the type of study (e.g. randomised, controlled), the endpoints and the statistical analysis methods.
• Population: Selection criteria for study participants, including inclusion and exclusion criteria and the size of the population to be analysed.

4. conduct and monitoring

• Implementation plan: Detailed plan for the conduct of the clinical investigation, including timelines and responsibilities of the parties involved.
• Monitoring and quality assurance: Procedures for monitoring the clinical investigation and ensuring data quality and integrity.

5. data management

• Data collection and processing: Description of the procedures for collecting, processing and storing study data to ensure its reliability and robustness.

6. risk management and safety monitoring

• Risk assessment: Analysis of potential risks to study participants and measures to minimise risk.
• Safety monitoring: procedures to continuously monitor the safety of study participants, including the reporting and assessment of adverse events.

7. informed consent and ethics

• Informed consent process: Description of the process for obtaining informed consent from study participants, including the provision of new information and compensation to participants.
• Ethics committee: Confirmation that the study has been approved by a competent ethics committee.

8. device accountability

• Appliance tracking and storage: procedures for tracking and storage of test appliances, including control of access and return of unused or defective appliances.

9. reporting and documentation

• Final report: Preparation of a final study report that summarises the results of the clinical investigation and is submitted to the competent authorities.
• Documentation and archiving: Ensuring that all relevant documents are prepared and stored in accordance with regulatory requirements. 10.

10. declarations of compliance

• Declarations of compliance: Confirmation that the clinical investigation is conducted in accordance with the ethical principles of the Declaration of Helsinki, the relevant international standards (e.g. ISO 14155) and national laws.

These elements form the basis, but are not comprehensive and adequate for every case. In order to create a comprehensive and compliant clinical investigation plan that fulfils the requirements of the relevant regulations and standards, serious and careful consideration must also be given to the need, objective of the entire project, budget and clear alignment with the strategic direction. Experienced experts should be involved in strategy development at an early stage.

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