Registering Ethics Proposal at BASEC and filling out BASEC project form

Introduction

This post ONLY describes how a medical device MR trial proposal can be submitted in Switzerland. In the EU this will different and will depend on the country and local ethics committee rules that apply. The post describes the data that was entered for the SIGNATURES2023 trial, and for your study this will be different in details. This post was added for completeness reasons, and strongly deviate for your medical device related trial.

The process of registering a project with BASEC (Business Administration System for Ethics Committees) and defining it as a “new project” involves key steps that bridge regulatory compliance, ethical considerations, and documentation management. BASEC, integral to Switzerland’s research ethics framework, ensures that projects align with national and international legal standards while safeguarding participant rights. For researchers, understanding these requirements is paramount, particularly when initiating clinical investigations or innovative methodologies. This article will walk you through the essentials of initiating a new project, highlighting the procedural milestones, regulatory nuances, and documentation essentials, ensuring a streamlined and ethically compliant start to your research endeavors.

Your registration consists of the following steps:

Creating a BASEC account and Log in

Your ethics application for all ethics committees in Switzerland are defined and documents uploaded via the BASEC website. One this BASEC homepage you find a Link to BASEC (log in page). Press this link and you are directed to login page. This page gives you the possibility to login to by BASEC by pressing the Login button located towards the top right of the page. You land on the BASEC login page. There you have to enter your user name and password. If you are not registered yet, register yourself and than login. If you have trouble logging in, be aware of Submission FAQ of BASEC, and consult this page first if necessary.

You are logged in at BASEC

After logging you view this page. This page allows the four different main tasks:

  • Goto the homepage (logged in)
  • Submit a new application
  • Manage my applications
  • My Account

Press the “Submit a new application” and you are directed to the define new project page.  On this web page there are seven possible options (date 17.12.2024) of which the first two are  relevant for MR research in general: 

  • Research Project Application Form
    • for research with CE-marked pulse sequences  and CE-marked RF-hardware
  • Research Project Application Form for Medical Devices / In Vitro Diagnostic Medical devices
    • for research with non-CE-marked pulse sequences and/or non -CE-marked RF-hardware

Choosing the Appropriate Submission Path

At this stage, you face a critical decision: If you are certain that only CE-marked product pulse sequences of your MR-scanner provider on CE-marked hardware will be used, you can proceed with the first option by clicking the “Submit an application” button. In this case, submission to your local ethics committee is sufficient, and Swissmedic involvement is not required. This path is the most straightforward and least time-consuming option for MR scientists. Such studies can typically be conducted as part of clinical-oriented projects or AI-focused MR research, where the MR scientist operates in a supportive role.

In contrast, many MR scientists will engage in studies involving non-CE-marked pulse sequences and/or non-CE-marked RF coils. These studies are vital for advancing the MR research field by exploring novel applications and pushing the boundaries of current knowledge. However, since the ClinO-MD became binding on 21.05.2021, the legal requirements for conducting this type of research have become significantly more time-consuming. For context, it took me seven months of full-time work spread across 25 months (from October 2022 to November 2024) to secure approval for a study—a type of research that MR scientists have been conducting for the past 40 years without such an extensive administrative burden. Again, if you read this blog posts carefully, I am sure that you can apply for a new project within two weeks full time work involving for you. If you want to speed it up even further you may be interested in having some documents being generated by a specially developed AI (GPT) for this purpose.

Finally, this blog will not cover the creation of an ethics proposal for the first type of study. Instead, it focuses specifically on medical device studies of the second type. For these studies, it may also be helpful to use the same AI tool (GPT) mentioned earlier to generate an initial draft of the Clinical Investigation Plan (CIP) required by your local ethics committee (local EC).

Filling out the BASEC form

Before starting your submission, carefully read the instructions provided on the BASEC website and consult the FAQ for additional guidance. It can save you a lot of work. Here is a summary of the instructions relevant for an MR-related medical device study.

Summary for Medical Device (MD) Studies Submission BASEC screen

Use the submission form to submit clinical investigations with medical devices (MD) that fall under the Ordinance ClinO-MD of July 1, 2020, to the ethics committee (EC).

  • Definition: A “clinical investigation” involves a systematic study with human subjects to evaluate the safety or performance of a medical device.
  • Submission Process:
    • Use the decision tree for clinical investigations with MD (flowchart diagram provided by Swissethics) to determine your research type and the responsible local EC authority.
    • Category C investigations must be submitted in parallel to Swissmedic on the same day as the EC submission.
  • Language Requirements:
    • For multicentric studies, all text fields must be completed in English.
    • For monocentric studies, the local language of the EC (German, French, or Italian) or English is acceptable.
  • Research Site Qualification: A site qualifies as a “research site” if it has a local investigator who signs the protocol and is responsible for its execution.
  • Submission Navigation:
    • Follow the order of the submission screens for accuracy, but navigation between screens is allowed.
    • The final “Submission Summary” screen will validate all inputs before submission. If validation fails, the system will highlight the required corrections.
  • Post-Submission:
    • Once started, applications are accessible under “My account / Manage my applications” and can be edited until submitted.
    • For amendments or additional documents (e.g., safety reports for SAEs, SUSARs, etc.), follow the specific instructions outlined in the FAQ.
    • Category C amendments or additional documents must also be submitted in parallel to Swissmedic.

By adhering to these guidelines, you can ensure a smoother and more compliant submission process for your MR-related MD clinical investigations.

Example Project

For an fictitious project involving non CE-marked sequences and RF hardware I entered the following information on the first page of the BASEC form the basic project details:

  • Project Basic Information
    • Title: My Cool MR-study with Handknit Experimental Pulse sequences using Non CE-marked Dual tuned RF-coils
    • Acronym: COOLMR
    • Internal Identification Number: N.A. (for companies only)
    • Existing Data/Material: No
    • Development Stage: Pilot stage
    • Other Countries: No (keep you life simple: multi country studies will add another layer of complexity; single center, single country is already hard enough)
      • Ethics Committee (EC)
    • Lead EC: [your local cantonal ethics committee] (choose your the correct local EC that handles the research of the canton your plan to perform your study)
    • Research Sites in Switzerland: One site
  • Clinical Trial Origin & Funding
    • Initiator: Investigator
    • Degree-related: No
  • Funding
    • Source #1: Public (Swiss National Science Foundation, SNF)
      • Amount: 400,000 CHF
      • Percent: 80%
    • Source #2: Public (International, EU)
      • Amount: 100,000 CHF
      • Percent: 20%
  • Declaration of Interests
    • Conflicts of Interest: No, there are no secondary (competing) interests.

Press the Next screen button at the bottom right ap the page to continue filling out the BASEC form, the so-called project details screen.

The first three choices of the bullet list below are critical. To figure out in which category your study is , please consult the flowchart diagram provided by Swissethics. The page requires the answers to the following issues (I marked my selections for my real project in blue):

  • Project Details
    • Type of Clinical Trial:
    • Medical devices (MD)
    • Medical devices/drugs (MD/IMP) – combined study
    • In vitro diagnostic medical devices (IVD-MD)
    • In vitro diagnostic medical devices (CDx)/drugs
  • Category of the Clinical Trial (ClinO-MD Art. 6 & 6a) (Remark: choose that what applies to your study)
    • A1
    • A2
    • C1
    • C2
    • C3
  • Classification
  • Primary Area of Research (Remark: choose that what applies to your study)
    • Treatment
    • Safety
    • Prevention
    • Diagnosis
    • Palliation
    • Rehabilitation
    • Other
  • Interventions (Remark: enter what applies to your study)
    • Describe intervention for each study arm, including duration, mode of administration, and control.
    • Methodological Categories (Remark: enter what applies to your study)
      • Allocation:
        • Randomised controlled trial
        • Non-randomised controlled trial
        • Not applicable
      • Masking Technique:
        • Open
        • Single-blind
        • Double-blind
        • Type of Control:
        • Sham/placebo
        • Active
        • Before-after (historic)
        • Dosage comparison
        • None
      • Arms/Distribution:
        • Single-armed
        • Parallel groups
        • Cross-over
        • Factorial
        • Other / N/A
  • Decentralized Clinical Trials (DCT) (Remark: enter what applies to your study)
    • The trial is a DCT or has decentralized elements
    • The trial is not a DCT and has no decentralized elements
  • Comparators (An investigational or marketed product (i.e., active control), or placebo, used as a reference in your clinical tria, e.g. a reference pulse sequence or reference hardwaree)
    • Is there a comparator, and is it a medical device?
      • Yes
      • No
  • Outcomes/Endpoints (Remark: enter what applies to your study)
    • Primary Outcome/Endpoint:
      • Add here main outcome for sample size calculation for your trial.
    • Secondary Outcomes/Endpoints:
      • List up to 4 secondary outcomes of your trial..
  • Participants
    • Number of Participants:
      • Total individuals to be enrolled in Switzerland.
    • Key Inclusion Criteria:
      • (800 characters max)
    • Key Exclusion Criteria:
      • (800 characters max) Remark: for my real proposal 800 characters were much too less, since after 5 iterations of my project evaluation process there were 40 (!) exclusion criteria. I informed BASEC on this, but did not change their website.
  • Vulnerable Persons (Remark: enter what applies to your study)
    • None
    • Embryos/foetuses
    • Children (0-13)
    • Adolescents (14-17)
    • Emergencies (transient incapacity to consent)
    • Pregnant women
    • Prisoners
    • Persons unable to consent (long-term)
    • Healthy volunteers (Remark: Interestingly patients are not deemed as vulnerable persons which is weird in an MR-trial, my reference trial include daddionally4 times 10 patients with different neurological disorders).
  • Timeline (Remark: enter what applies to your study)
    • Start Date:
      • Date of first patient enrolment (DD.MM.YYYY).
    • End Date:
      • Date of last patient visit (DD.MM.YYYY).
  • Ionising Radiation (Remark: choose that what applies to your study)
    • Does the study involve ionising radiation?
      • No
      • Yes, main focus is MDs emitting radiation
      • Yes, radiation is for accompanying evaluations (e.g., imaging)

Press the “Next screen” button on the lower right of the page. You will than land on the “Further use” screen. If your study does not include any further use of data/tissues than you can skip this page. Press the “Next screen” button on the lower right of the page and you land on the SNCTP screen which collects all information needed to register your studyon the Swiss National Clinical Trials Portal (SNCTP) see HRA art. 56 paragraph 1 ( DE , FR , IT ).. This page will collect the following information items:

  • Language used for SNCTP
    • German/French/Italian
  • Lay title
    • “MR-study for you”
  • Illness or state of health studied
    • Sickness type 1,
    • sickness type 2, etc. ….
  • Lay summary
    • Enter the lay summary of your study using simple wording
  • Interventions studied
    • Elaborate on e.g. what applies to your study:
      • MR-exam(s) using non- CE-marked experimental pulse sequences
      • MR-exam(s) using no-CE-marked experimental MR hardware
  • Inclusion criteria List only the most important inclusion criteria (maximum three criteria).
    • Inclusion Criterion-1, inclusion criterion-2, etc …
    • Remark: for my real proposal 800 characters were much too less, since after 5 iterations of my project evaluation process there were 40 (!) exclusion criteria. I informed BASEC on this, but did not change their website.
  • Exclusion criteria
    • List only the most important exclusion criteria (maximum 3 criteria).
    • Exclusion criterion 1, Exclusion criterion 2 ..
    • Remark: for my real proposal 800 characters were much too less, since after 5 iterations of my project evaluation process there were 40 (!) exclusion criteria. I informed BASEC on this, but did not change their website.
  • Main study location
    • Aarau
    • Basel
    • Bellinzona
    • Bern
    • Chur
    • Fribourg/Freiburg
    • Geneva
    • Lausanne
    • Lugano
    • Lucerne
    • Neuchâtel
    • Zion
    • St. Gallen
    • Winterthur
    • Other location: specify
  • Contact for further information?  The information you provide will be published on the SNCTP website, and may therefore lead to inquiries by the general public,  so fill out the following fields
    • Your full name
      • Harold Smartperson
    • Phone: +41-31-12345678
    • E-mail: harold.smartperson@smarties.ch
  • Primary Registry Note : At the time of your initial submission you may not yet have the information to fill in the next two fields. You can add the information later, after receiving the approval from the Ethics Committee (see this FAQ-entry on how to submit updates).
  • External identification number (ID)
    • Number format for ClinicalTrials.gov : Prefix NCT + 8 digits
    • Example : NCT02217865
  • Disease under investigation
    • Please select 1 or more keywords from the catalog below: The keywords are used to narrow the search function for trials in the SNCTP.
      • Arterial and venous diseases including deep venous thrombosis and lung embolism
      • Basic research (Anatomy/Physiology)
      • Brain diseases (non-cancer)
      • Cancer: Bladder
      • Cancer: Breast
      • Cancer: Colon and Rectal
      • Cancer: Endometrial
      • Cancer: Head and Neck
      • Cancer: Lymphoma
      • Cancer: Kidney
      • Cancer: Leukemia
      • Cancer: Lung
      • Cancer: Melanoma
      • Cancer: Non-Hodgkin Lymphoma
      • Cancer: Pancreatic
      • Cancer: Prostate
      • Cancer: Thyroid
      • Cancer: Other
      • Coronary heart disease
      • Dementia and Alzheimer disease
      • Digestive Systems diseases (non-cancer)
      • Ear, Nose, and Throat diseases (non-cancer)
      • Endocrinological diseases (non-cancer)
      • Eye diseases
      • Genetic disorders
      • Hematologic diseases (non-cancer)
      • Infections and Infestations
      • Injury
      • Mental and Behavioral diseases
      • Musculoskeletal diseases (non-cancer)
      • Neonatal diseases
      • Nervous System Diseases
      • Nutritional and Metabolic diseases
      • Occupational diseases
      • Periodontal diseases
      • Pregnancy and Childbirth
      • Respiratory diseases (non-cancer)
      • Skin and Connective Tissue diseases (non-cancer)
      • Surgery
      • Urological and Genital diseases (non-cancer)
      • Other
    • Investigation of a rare disease? A rare disease or orphan disease is defined as a disease or condition that affects fewer than 5 in 10,000 people and is life-threatening or chronically debilitating. To determine whether your project meets the criteria for an orphan disease, please visit orpha.net .

 Press on the button “Next screen” to proceed with defining your BASEC application. You land on the “Adresses” screen:

  • Principal/coordinating investigator in Switzerland*
    • See ClinO-MD art.2: “Investigator means a person responsible in Switzerland for the conduct of a clinical trial and for the protection of the participants at the trial site; an investigator who takes responsibility for organising a clinical trial in Switzerland is also a sponsor.”
    • See ClinO-MD art.13: “The coordinating investigator is the person responsible in Switzerland for coordination of the investigators responsible at the individual trial sites, in a multicentre clinical trial.”
      • Sex
        • your sex 
      • Title
        • your title 
      • First name
        • Harold
      • Last name
        • Smartperson
      • Organisation
        • Your organisation name
      • Address lines
        • Your department, clinic name.
        • Your address
      • Zip Code
        • your zip code 1234
      • City
        • Your city
      • Email
        • harold.smartperson@smarties.ch
      • Telephone
        • +41-31-12345678
  • Sponsor
    • See ClinO-MD art.2: “Sponsor” means a person or institution that takes responsibility for organising a clinical trial, and in particular for the initiation, management and financing of the trial in Switzerland. If the principal investigator assumes the role of the sponsor (in an investigator-sponsored trial), please enter here again the address, name and contact details of the investigator.
    • Address of Sponsor
      • Organisation
        • e.g. [your research institute]
      • Ms/Mr
        • Mr
      • Title
        • e,g, Dr
      • First Name
        • Harold
      • Last Name
        • Smartperson
      • Address lines (e.g.: Unit, department, street.)
        • Your address (if you are sponsor/investigator)
        • Zip Code
        • 1234
      • City
        • e.g. [town of your research facility]
      • Country
        • Switzerland
      • Email
        • harold.smartperson@smarties.ch
      • Telephone (Please include the country prefix. E.g.: +41…)
        • the phone number of the sponsor/investigator (that is you)
  • Sponsor’s representative in Switzerland
    • See ClinO-MD art. 4: The sponsor’s representative in Switzerland must be designated by a sponsor that has neither a registered office nor a branch in Switzerland. The sponsor’s representative must ensure compliance with the sponsor’s obligations set in ClinO-MD art. 2.
      • There is no sponsor’s representative in Switzerland (i.e. the sponsor is located in Switzerland)
      • There is a sponsor’s representative (i.e. the sponsor is located abroad)
  • CRO (Contract Research Organisation)
    • There is no CRO (in the case of this example as well as in real case on which this blog is based)
    • There is a CRO
  • Manufacturer of the medical device
    • Single registration number (SRN) See: Art. 31 MDR (EU) 2017/745.
      • enter the registration number of you coil manufacturer (SNR)
    • Organisation
      • Cool RF-Coils Unlimited, UK
    • Ms/Mr
      • Mr
    • Title
      • Mr
    • First Name
      • John
    • Last Name
      • Coilbuilder
    • Address Lines (e.g.: company name, Unit, department, street.)
      • Coil company address,…, UK
    • Zip Code
      • AX123D
    • City
      • City in UK
    • Country
      • United Kingdom
    • Email
      • john.coilbuilder@cool-rf-coils-unlimited.uk
    • Telephone (Please include the country prefix. E.g.: +41…)
      • +4412345678910
  • Applicant
    The applicant must be one of the four possibilities listed below, see ClinO-MD art. 10 Choose principal investigator if the sponsor and the principal investigator are the same person, and this person is the applicant. Choose CRO if the CRO and the sponsor’s representative in Switzerland are the same person, and this person is the applicant.

    • The applicant is:
      • Principal / coordinating investigator in Switzerland
      • Sponsor
  • Billing address (Please note: Fees apply to the evaluation of research projects submitted to ethics committees (art. 54 HRA). Fees are billed according to this scale of fees. the billing address must be located in Switzerland. Please take extra care to ensure that the billing information is correct.)
    • For billing use the address of the
      • Principal / coordinating investigator in Switzerland
      • Sponsor
      • Other
    • Additional billing instructions
      • None
  • Maximum of 3 additional contacts.
    • Other contact information
    • Please use this section to add any other important contact information (e.g. study-nurse). Maximum of 3 additional contacts.

This finalizes the “Adresses” screen (number 5). All screens discussed above, are short simple textual information. The next screen (number 6)  with titled “Lead EC: General and main site’s documents” contains the application files itself and is very large. You can view this in the post with the title “Lead EC: General and main site’s documents” of this blog.

Uploaded documents to BASEC for a Real and Approved Project

Category/Type Filename Date of Document Version
Cover Letter accompanying-letter….pdf 11.10.2024 NA
Investigator’s Brochure (IB) investigator-brochu…ures2023-clean.pdf 11.10.2024 V5.0-clean
Investigator’s Brochure (IB) investigator-brochu…tures2023-diff.pdf 11.10.2024 V5.0-diff
General Safety & Performance Req. siemens-conformance…cumentation-v2.zip 18.03.2024 V2.0
General Safety & Performance Req. glucose-related-standards-basec-v2.zip 18.03.2024 V2.0
General Safety & Performance Req. [your 3rd party RF-coil manufacturer]-docs-v5.zip 11.10.2024 V5.0
General Safety & Performance Req. risk-analysis-plan-report-basec-v2.zip 18.03.2024 V2.0
Clinical Investigation Plan (CIP) cip-v-5-0-signature…11102024-clean.pdf 11.10.2024 5.0-clean
Clinical Investigation Plan (CIP) cip-v-5-0-signature…-11102024-diff.pdf 11.10.2024 5.0-diff
Case Report Form (CRF) allcrfs-11102024-v5-0-clean.zip 11.10.2024 V5.0-clean
Case Report Form (CRF) all-crfs-11102024-v5-0-diff.zip 11.10.2024 V5.0-diff
Principal Investigator CV 07-cv-johannes-slotboom-03-2024.pdf 18.03.2024 NA
Sponsor Evidence 09-gcp-course-advan…rse-j-slotboom.pdf 18.03.2024 NA
Staff List 16-signatures2023-staff-list-v2.pdf 13.03.2024 NA
GCP Training Proof signatures2023-gcp-course-j-slotboom.pdf 31.01.2023 NA
Agreement 01-contractsponsorm…erstatement-v2.pdf 13.03.2024 NA
Agreement [your 3rd party RF-coil manufacturer]-[your research institute]-contract.pdf 16.05.2024 NA
Statement of Conformity signatures2023-manu…onfirmation-v2.pdf 12.03.2024 V2.0
Statement of Conformity risk-analysis-plan-report-basec-v2.zip 18.03.2024 V2.0
Insurance police-probandenver…ersicherung-01.pdf 31.01.2023 NA
Participant Info & Consent flyer-gesunde-proba…s2023-v4-clean.pdf 03.06.2024 V4.0-clean
Participant Info & Consent flyer-gesunde-proba…es2023-v4-diff.pdf 03.06.2024 V4.0-diff
Participant Info & Consent studieninformation-…s2023-v4-clean.pdf 03.06.2024 V4.0
Participant Info & Consent studieninformation-…es2023-v4-diff.pdf 03.06.2024 V4.0-diff
Miscellaneous list-of-documents-n…-v1-clean.pdf 21.05.2024 V1
Miscellaneous risk-related-docs-v2-signatures2023.zip 13.03.2024 V2
Monitoring Plan signatures2023-moni…-plan-v3-clean.pdf 06.09.2024 V3-clean
Monitoring Plan signatures2023-moni…g-plan-v3-diff.pdf 06.09.2024 V3-diff
Email Submission email-binggeli-rech…2024-submitted.pdf 23.10.2024 NA
Cover Letter Submission accompanying-letter…2024-submitted.pdf 24.10.2024 NA

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