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Submission of an ‘Advice on ethical questions/comments on research projects not subject to the HRA’

Articles in this category

BASEC – Quick start

In order to submit applications for research projects according to the Swiss Human research act of 2014, please use the online portal BASEC. All Swiss Ethics Committees (on research involving humans) ...

56,753
(29)
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...

1,790
(5)
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...

15,048
(41)
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...

7,592
(7)
How to submit amendments, new documents or update fields of a submission?

Update, 11.10.2018 The article below explains the update procedure for projects that were initially submitted through BASEC (submissions.swissethics.ch). For a first update to projects that were initi...

54,816
(429)
How to request a transfer of a project to another account

If you need to hand over a project to a new organisation/person, you can request a transfer of the project form from your account to another account. The request for the transfer is done by the curren...

4,595
(44)
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

12,118
(27)
  • Top articles
  • Latest articles
BASEC – Quick start

Category: Knowledgebase

In order to submit applications for research projects according to the Swiss Human research act of 2014, please use the online portal BASEC. All Swiss Ethics Committees (on research involving humans) ...

56,753
(29)
How to submit amendments, new documents or update fields of a submission?

Category: Knowledgebase

Update, 11.10.2018 The article below explains the update procedure for projects that were initially submitted through BASEC (submissions.swissethics.ch). For a first update to projects that were initi...

54,816
(429)
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...

15,048
(41)
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...

7,592
(7)
New BASEC frontend interface

Category: Knowledgebase

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...

1,790
(5)
Submission of safety reports (SUSARs, SAEs, Safety Status Reports/DSUR etc.)

Category: Safety Notifications

This procedure is effective from 11 June 2018 How do I use the safety form? How do I submit safety reports, like SUSARs, SAEs, Safety Status Reports/DSUR, etc. or notify the EC of immediate safety and...

27,900
(211)
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...

135
(1)
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 ...

460
(3)
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...

483
(0)
Submission of an ‘Advice on ethical questions/comments on research projects not subject to the HRA’

Category: Submission of an ‘Advice on ethical questions/comments on research projects not subject to the HRA’

When can I ask for a comment on research projects not subject to the HRA?  For which ethical questions can I ask the EC for an advice?" The form addresses the duties according to Art. 51 lit 2 HRA. It...

5,344
(4)
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   Definitions: When does a study (a clinical trial or a research project) end? The end of a study involvin...

12,118
(27)
Submission of PW-protected files

Category: Misc

Please do not submit password-protected files through BASEC. Everything you submit through the BASEC forms is encrypted before it’s transferred from your Computer to the BASEC-server (by using the htt...

1,282
(11)