Introdução à Neurociência

This form is intended to collect information regarding a Clinical Study Proposal and apply for assessment and approval by the Clinical Vision Team. This form is limited to study proposals related to Cardiac Rhythm Management (Pacemaker, ICD, CRT, EP). Please complete this form in detail and return to BIOTRONIK Center for Clinical Research (CCR). Please e-mail to: [e-mail] Completed Clinical Study Application Forms will be reviewed by the Center for Clinical Research for potential application to the Clinical Vision Team of BIOTRONIK. Completing this form does not guarantee project approval. Previous commitments to physicians/customers have to be omitted.

Application date (DD. MMM YYYY):	.
Original Proposer of this Study Idea *
BIOTRONIK Contact Person (and internal representative)
Responsible Regional Clinical Interface
Proposal on countries to be involved
Concerned product           (please inscribe product name)
Persons involved in the genesis of the study proposal (sorted according to importance of contribution)
Signature of applicant
	Date	Name

*) If applicable please indicate the specific qualification/area of influence/opinion leadership on a separate sheet

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1. Study Rationale and Objectives Please describe in detail the rationale and objectives for the proposed study:
1.1	Which clinical question shall be answered?
1.2.	To what degree has this question already been investigated elsewhere? What are the differentiators to already published studies?
1.3.	Can this question only be answered by a clinical investigation?
1.4	Why and for whom (primary addressees) is it important to perform this study?
1.5	What and how will BIOTRONIK technology be used (devices, Home Monitoring, CLS, …)?
1.6	Is the device approved for this indication used in this study?
1.7.	Is the planned investigation justified by the guidelines? (e.g. which indication class)
1.7	What and how will other technologies be used (Echo, 24-hour Holter, …) to assess the Primary Endpoint?
1.8	What and how will other technologies be used to assess Secondary Endpoints?
1.9	Is there any limitation of the Study Objective regarding regions, patients etc.

2. Existing experiences and results from literature
2.1	What are the existing studies and/or results that support the study idea? (Please provide key literature references if available).
2.2	PubMed.gov:
2.3	ClinicalTrials.gov: (or comparable studies)
2.4	Summary of literature search:

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3. Study Design Please describe in detail the proposed study design. Give estimates or proposals where the final information is still uncertain. Please include:
3.1	What is the proposal for?	Single-site study ☐                Multi-site study ☐
3.2	How many patients at how many sites?
3.3	What is the basis for this sample size assessment?
3.4	What is the basis for the number of sites?
3.5	What is the intended patient population?
3.6	What are the specific inclusion criteria?
3.7	What are the specific exclusion criteria?
3.8	What is the proposed primary endpoint?
3.9	What are the proposed secondary endpoints? (if any, please justify)
3.10	What data will be collected to evaluate the endpoints? (please specify)
3.11	Can you indicate a preliminary statistical hypothesis? (if possible at this time and for primary endpoint only)
3.12	Pilot or Pivotal Study (if pilot, towards which pivotal design?)
3.13	Further study design characteristics	e.g.        ☐ prospective or         ☐ retrospective         ☐ randomized or         ☐ non-randomized         ☐ blinded or                 ☐ unblinded

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4. Projected Timelines / Duration according to your current management plans:
4.1	Please provide your intended study start date (enrollment of first patient):
4.2.	Is the study start date dependent on other conditions	☐  no         ☐  yes                ⇒ please specify:
4.3	What is the projected enrollment period in years / months (from first until last patient in):
4.4	What is the projected follow-up period (per patient)?

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