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Articles in this category

BASEC – Quick Start Guide

1. What is BASEC? BASEC (Business Administration System for Ethics Committees) is the online portal you must use to submit applications for research projects according to the Human Research Act (HRA)....

5,617
(0)
New BASEC frontend interface

The submission portal at https://submissions.swissethics.ch has a new graphical interface with new features that are explained below. Login The “Login” button is now located at the top right corner in...

5,092
(5)
What about checklists for documents?

The list of documents required for the submission of clinical trials, according to ClinO, and the list of documents required for the submission of a research project, according to HRO, can be found on...

9,682
(7)
How to request a transfer of a form to another account

The following procedure applies to any BASEC form, i.e., project form, safety form, Req form, ... If you need to hand over a project to a new organisation/person, you can request a transfer of the pro...

7,152
(47)
How to collaborate on a submission

Collaborating via the submission form The submission form allows to invite other people to collaborate on a submission. The project owner manages the rights to access and to contribute to the research...

18,663
(44)
How to submit amendments, new documents or update fields of a submission?

Update, 23.01.2025 The article below explains the update procedure for projects initially submitted through BASEC. Preliminary notes: Use the form SAFETY FORM to submit safety documents

66,492
(439)
How to submit a request for the extension of the project

How to submit a request for the extension of the project An extension of the project because the expected start was delayed, or because the recruitment period needs to be extended, is submitted to the...

5,377
(5)
How to submit a new investigational site to an approved study.

The notification to open a new research site must be submitted to the Lead ethics committee as a substantial amendment.  go to your account-->manage my applications, find the project you want to u...

1,260
(1)
Submission of end of study (clinical trial or research project) to the ethics committee

When and how to notify the end of a clinical trial / research project to the Ethics Committee

29,829
(47)
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How to submit amendments, new documents or update fields of a submission?

Category: Knowledgebase

Update, 23.01.2025 The article below explains the update procedure for projects initially submitted through BASEC. Preliminary notes: Use the form SAFETY FORM to submit safety documents and follow the...

66,492
(439)
Submission of end of study (clinical trial or research project) to the ethics committee

Category: Knowledgebase

When and how to notify the end of a clinical trial / research project to the Ethics Committee   Index: 1. Definitions2. When should the regular end of a study be reported and to whom?3. When should th...

29,829
(47)
How to collaborate on a submission

Category: Knowledgebase

Collaborating via the submission form The submission form allows to invite other people to collaborate on a submission. The project owner manages the rights to access and to contribute to the research...

18,663
(44)
What about checklists for documents?

Category: Knowledgebase

The list of documents required for the submission of clinical trials, according to ClinO, and the list of documents required for the submission of a research project, according to HRO, can be found on...

9,682
(7)
How to request a transfer of a form to another account

Category: Knowledgebase

The following procedure applies to any BASEC form, i.e., project form, safety form, Req form, ... If you need to hand over a project to a new organisation/person, you can request a transfer of the pro...

7,152
(47)
BASEC – Quick Start Guide

Category: Knowledgebase

1. What is BASEC? BASEC (Business Administration System for Ethics Committees) is the online portal you must use to submit applications for research projects according to the Human Research Act (HRA)....

5,617
(0)
How to submit a new investigational site to an approved study.

Category: Knowledgebase

The notification to open a new research site must be submitted to the Lead ethics committee as a substantial amendment.  go to your account-->manage my applications, find the project you want to u...

1,260
(1)
How to submit a request for the extension of the project

Category: Knowledgebase

How to submit a request for the extension of the project An extension of the project because the expected start was delayed, or because the recruitment period needs to be extended, is submitted to the...

5,377
(5)
Notification of the first visit of the first participant

Category: Screen 6 (Main uploads)

Article 38, paragraph 1a of the Ordinances on Clinical Trials in Human Research (ClinO) requires that the investigator shall notify the ethics committee, within 30 days, of the first visit of the firs...

2,786
(3)
How to submit a combined study with a medicinal product and a companion diagnostic IVD (CDx) or other IVD studies the Ethics Committee

Category: Misc

Definitions: In vitro diagnostic medical device (IVD) is defined in Art 3 of the Swiss Ordinance on In Vitro Medical Devices (IvDO) and in Art. 2 (2) of the EU-IVDR, as any medical device which is a r...

6,422
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Problems with skipping screens

Category: Screens 7 to 13 (uploads local ECs)

Skipping screens on local center screens If you experience a skipping form screen on screens 7 to 13 in the Research project application form or the MDR form, it's usually because you click too early ...

1,167
(4)
When should the Pre-BASEC research project form be used and when it shoudn't?

Category: Submissions/Updates for old projects (pre-BASEC)

If the project has a BASEC ID number with the format PB_YYYY-xxxxx, it means that there is a Pre-BASEC form in BASEC for that project. Submission of a substantial amendment to a project that has a Pre...

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