Clinical Grant

Step 1: Complete and submit IIT application. You can save your progress and log back in to finish if needed.

Step 2: The following documents are required for submission. Please provide in a PDF format:

• Current CV signed and dated (Note: All sensitive information i.e., DOB, Social Security Number should be removed
  
  prior to submission). Once submitted, the application is reviewed for completeness.

If the IIT request meets the initial requirements, the approval process begins with a scientific review by a board

of BIOTRONIK experts to ensure merit, significance and available funding. The CRM and VI boards meet every quarter.

The applicant will be informed via email once the Board Committee decision is made. Request for further

information, if any, will be provided to the applicant throughout the review process.

We mindfully review all IIT requests with a detailed assessment by a cross-functional team.

 

IIT Requests will be assessed with the following criteria:

• Scientific Merit
• Method: study design, justified sample size, eligibility criteria, primary and main secondary endpoints, timelines,
• Consistency of the requested budget with proposed study
• Correlation with clinical strategy
• Health economics or reimbursement purposes
• Adequate research experience and infrastructure to conduct the study
• Research should address new ideas, new fields, explore gaps in existing knowledge

Definitions:

Sponsor (ISO14155:2020): Individual or organization taking responsibility and liability for the

initiation or implementation of a clinical investigation.Principal Investigator (ISO14155:2020): Qualified person

responsible for conducting the clinical investigation at an investigation site.

Responsibilities:

Sponsor (ISO14155:2020):

8.1 Clinical quality assurance and quality control

8.2 Clinical investigation planning and conduct

8.2.1 Selection of clinical personnel

8.2.2 Preparation of documents and materials

8.2.3 Conduct of clinical investigation

8.2.4 Monitoring

8.2.5 Safety evaluation and reporting

8.2.6 Clinical investigation close-out

Principal investigator (ISO14155:2020)

The role of the principal investigator is to implement and manage the day-to-

day conduct of the clinical investigation as well as ensure data integrity and the rights, safety and well-being

of the subjects involved in the clinical investigation. Understand and act in accordance with MedTech

requirements, guidelines and laws.

Please refer to the ClinicalTrials.gov Protocol Registration and Results System

Final Rule Information website. https://prsinfo.clinicaltrials.gov/

Design the protocol and conduct the scientific investigation.

Gain approval through Institutional Review Board (IRB) / Independent Ethics Committee (IEC).

Register study. Click this link to learn how. https://clinicaltrials.gov/ct2/manage-recs/how-registerControl study protocol

and manage the data generated during the study.Submit study status updates as required in the study agreement.

Notify the company of significant study milestones as required in the study agreement.

Provide a draft manuscript and study data upon completion of the study.

Report safety data to regulatory authorities, the IRB/IEC,

and the company.

Understand and comply with any and all requirements of institution(s) which are associated or

which research will occur.