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SWISSETHICS

Schweizerische Vereinigung der Forschungsethikkommissionen

Swiss Association of Research Ethics Committees

BASEC FAQ
swissethics BASEC submission FAQ BASEC FAQ
Knowledgebase

SUGGESTED KNOWLEDGEBASE ARTICLES:


KNOWLEDGEBASE

MY ACCOUNT

 * My Project is approved, but the status in the submission portal is „Draft
   update“?

SAFETY NOTIFICATIONS

 * Submission of safety reports (SUSARs, SAEs, ASR/DSUR etc.)

SCREEN 1

 * I filled out the form for non-clinical trial and just realised it’s a
   clinical trial. Will I lose all my data?

SCREEN 4 (SNCTP)

 * Registration in the Swiss National Clinical Trials Portal (SNCTP)

SCREEN 6 (MAIN UPLOADS)

 * Overview of submission documents

SCREENS 7 TO 13 (UPLOADS LOCAL ECS)

 * Problems with skipping screens

SCREEN 14 (SUBMISSION SUMMARY)

 * Submission of signed form (after electronic submission)
 * I can't submit
 * I can’t print the PDF file

MISC

 * Research projects involving human embryonic stem cells
 * Retention period for drafts never submitted
 * Submission of PW-protected files

SUBMISSIONS/UPDATES FOR OLD PROJECTS (PRE-BASEC)

 * Submissions of changes to ongoing projects that are not in BASEC yet
 * When should the Pre-BASEC research project form be used and when it shoudn't?

TECHNICAL PROBLEMS

 * I get script warnings in Firefox
 * File size limits
 * Browser jumps to another screen

CLARIFICATION OF RESPONSIBILITY / GENERAL QUESTIONS

 * Submission of a clarification of responsibility (formerly : 'jurisdictional
   enquiry')

SUBMISSION OF AN ‘ADVICE ON ETHICAL QUESTIONS/COMMENTS ON RESEARCH PROJECTS NOT
SUBJECT TO THE HRA’

 * 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) ...

54,554

(28)


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...

1,356

(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...

14,590

(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...

7,368

(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...

53,165

(426)


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...

4,408

(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

11,264

(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) ...

54,554

(28)


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...

53,165

(426)


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...

14,590

(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...

7,368

(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...

1,356

(5)


SUBMISSION OF SAFETY REPORTS (SUSARS, SAES, ASR/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, ASR/DSUR, etc. or notify the EC
of immediate safety and protective measur...

26,830

(211)

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 ...

332

(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...

276

(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...

5,010

(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...

11,264

(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...

1,186

(11)


SUBMISSION OF A CLARIFICATION OF RESPONSIBILITY (FORMERLY : 'JURISDICTIONAL
ENQUIRY')

Category: Clarification of responsibility / general questions

When should I submit a clarification of responsibility? A clarification of
responsiblity1 (formerly: jurisdictional inquiry) is submitted to the ethics
committee (EC) to clarify whether the research p...

10,368

(18)


GESCHÄFTSSTELLE SWISSETHICS

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Telefon: +41 31 306 93 95 (Mo-Do)
Email: info@swissethics.ch


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