Antrag Projektfoerderung E

swissethics Schweizerische Ethikkommissionen für die Forschung am Menschen
Commissions d’éthique suisses relative à la recherche sur l'être humain

Commissioni etiche svizzere per la ricerca sull'essere umano
Swiss Ethics Committees on research involving humans
Required documents/information for clinical trials

(table for non-clinical research starts on page 6)
R= This document/information is required. In BASEC this is labelled with an asterisk < * >
A= Mandatory if applicable (for example a contract between an investigational site and the sponsor is mandatory
while the document is not requested in an investigator initiated trial with no external sponsor or any other external
collaborator). In BASEC this is labelled with an asterisk in parentheses < (*) >.
Clinical trials
medicinal
gene therapy or Other
products and medical Trans-
Study type: pathogenic/genetically clinical
transplant devices plantation
modified organisms trials
products
Document
number in
BASEC
Risk category A B C A C A B C A C A&B
1 Covering letter R R R R R R R R R R R
Synopsis of the study plan
A separate synopsis is not required. A
synopsis is generally already included
in the protocol.
2 (Multicentre clinical trials in the A A A A A A A A A A A
language of the Lead EC or in English.
Monocentric trials in the language of
the EC.)
Template (.docx) in DE, FR, IT, EN
available at swissethics.ch
Participant information sheet and
informed consent (ICF)
3 • Template for drafting information for R R R R R R R R R R R
participants (.docx) in DE, FR, IT
Study plan (protocol), signed and
dated
4 R R R R R R R R R R R
Clinical Protocol Template for (.docx)
in EN available at swissethics.ch
CRF (Case Report Form)
Draft acceptable provided the final
5 document is available within the next R R R R R R R R R R R
30 days (monocentric) or 45 days
(multicentric). Optional for non-clinical
projects.
Investigator's / Project Leader's CV,
dated
7 Investigator’s proof of GCP training R R R R R R R R R R R
Details on infrastructure suitability
8 and availability at the location A A A A A A A A A A A
where the trial is executed
document matrix last update: 09.11.2016 page 1/11

Clinical trials
medicinal
products
Document
number in
BASEC
Agreement between
sponsor/commissioned institution /
grant provider or other third parties
and the investigator
Regarding trial financing, the
allocation of tasks, the investigator’s
9 compensation and the publication. A A A A A A A A A A A
Template (.docx) in EN available at
swissethics.ch
document is available within the next
30 days (monocentric) or 45 days
(multicentric).
Insurance
General Insurance Conditions (GIC)
for clinical trials in Human Research
10 (.pdf) in DE, FR, EN and A R R A R A R R A R A/R
Insurance (template) for clinical
trials (.docx) in DE, FR, IT, EN
Other documents handed over to
study participants
Such as advertisements used in
11 recruitment, patient journals, A A A A A A A A A A A
questionnaires, scores, translations of
study documents, recruitment letters
etc.
Details on nature and scope/value

of compensation for participants
Other personnel
13 Template (.docx) in EN available at A A A A A A A A A A A
swissethics.ch
Information on secure handling of

biological material and personal
data, and in particular on the
14 storage thereof R R R R R R R R R R R
According to art. 18 ClinO (in DE, FR,
IT) and art. 5 ORH (in DE, FR, IT).
Information on reviews of this

proposal by other Ethics
15 A A A A A A A A A A A
Committees, or Regulatory
Authorities (Foreign or Swiss)
Professional information as
approved by Swissmedic
16 R R R
Please copy relevant information from
Swissmedic and upload here.

Clinical trials
medicinal
products
Document
number in
BASEC
Deviation from the prescribing

17 information according to the study R R
plan
Proof of proper labelling of the
therapeutic products and
compliance with Good
manufacturing Practice
18 Please send us a description and/or a R R R
sample of your study specific label.
The GMP part has only to be
answered if non proprietary products
are used e.g. repacked medicinal
products.
Investigator's Brochure (IB):
Current clinical and non-clinical
19 R R R
information on the product under
investigation and its components
Conformity marking and deviation
from indented use
For clinical trials of a medical device
bearing a conformity marking which
20 is not used in accordance with the R
intended purpose or the instructions:
Please provide the relevant
documentation according to ClinO,
Annex 4, Points 3.5 a. to d. (link
in DE, FR, IT).
Information on the conformity of
the medical device (CE marking
21 from a notified body) R
According to ClinO, Annex 3, point
1.8. (DE, FR, IT).
Intended use of Medical Device and
instructions
22 R
According to ClinO, Annex 3, point
1.8. (DE, FR, IT).
Information about gene therapy as

specified in Annex 4 chapter 4 of
the Ordinance on Clinical Trials
23 ClinO A R R
ClinO, Annex 4, Chapter 4.
(DE, FR, IT).
Details regarding the information

24 R R
and consent of the donor

Clinical trials
medicinal
products
Document
number in
BASEC
Proof of the origin & quality of the

organs, tissues, or cells used
25 In particular list all the tests, which R
have been performed in this
connection.
Proof of compliance with duties of

care
26 Particularly with regard to the R
assessment of fitness to donate and
mandatory testing, and the procedure
in the event of reactive text results.
Authorisation
Copy of the authorisation letter, if the
27 handling of the organs, tissues or cells A
used is subject to authorisation under
the Transplantation Act (link
in DE, FR, IT).
Transplantation using genetically
modified human organs, tissues or
cells
28 Provide all further documents as listed R R
in Annex 4, chapter 6.7 of the
Ordinance on Clinical Trials
ClinO (DE, FR, IT).
Table with values of estimated
effective radiation dose
The calculation of the effective dose
must take into account all radiation
sources used in the study and must
include the uncertainty according to
Art. 28 (DE, FR, IT) Radiological
Protection Ordinance from 1994
(Effective Dose + uncertainty < 5
mSv).
If you do not already have tables with
values of the estimated effective
radiation dose you can download a
template of the table here.
Required authorisation for the use
of ionising radiation according to
article 28 of the radiological
35 protection act A A A A A A A A A A A
See: Article 28 of the Radiological
Protection Act of 22 March 1991 (link
in DE, FR, IT).
Further documents as listed in

Annex 2, chapter 3 of the HRO

Clinical trials
medicinal
products
Document
number in
BASEC
Provide all further documents as listed

in Annex 2, chapter 3 of the Human
Research Ordinance
HRO (DE, FR, IT).
Further documents as listed in
Annexe 3, chapter 6 of the ClinO
37 Please provide all further A A A A A A A A A A A
documents as listed in Annexe 3,
chapter 6 of the Ordinance on Clinical
Trials ClinO (link in DE, FR, IT).
Sponsor's delegation letter, signed
If the sponsor's representative or the
38 CRO acts as applicant, a delegation A A A A A A A A A A A
letter of the sponsor is required. If this
information is contained in a contract,
please upload this document.
Miscellaneous / Varia
39 Please only add documents that don't A A A A A A A A A A A
fall in one of the above categories.
Further information:
The document list on the upload screen/s in BASEC will be generated automatically depending on your
entries on screens 1-3.
In BASEC you will find links to templates and further information under each document category on the
upload-screens. (All templates are also available on www.swissethics.ch)
Some information necessary for further use studies is already asked in the application form.
Contracts with sponsors or grand providers for further use studies are required if existing although the item
was forgotten in the appendix of the ordinance.
Documents that have to be signed are the following: protocol (item 4), contract(s)/letter of delegation (item
9, 38), insurance (item 10), and staff list (item 13).
Combined trials with medicinal products and medical devices need all the required documents from both
types.
Other important documents not falling within these categories can be uploaded in the miscellaneous category
"Varia".
If you have questions that are not answered in the help/FAQ section of BASEC, please contact your
local EC

Required documents/information for non-clinical research projects

non-clinical research
including persons
further use of health related data
(Sampling /
and/or biological material
Collection)
Document including
including
number in Study type embryos &
deceased
BASEC foetuses with consent,
Risk A Risk B with consent to without consent
be sought
1 Covering letter R R R R R R
Synopsis of the study plan
A separate synopsis is not required for
research projects (HFV, ORH, ORUm) if
the protocol is shorter than 20 pages.
2 (Multicentre clinical trials in the language R R R R R R
of the Lead EC or in English. Monocentric
trials in the language of the EC.)
3 • Template for drafting information for R R R
participants (.docx) in DE, FR, IT available
at swissethics.ch
Study plan (protocol) (signed and
dated)1
4 Project Plan Template (HRO Art. 6) for R R R R R R
Human research other than clinical trials,
(.docx) in EN available at swissethics.ch
CRF (Case Report Form)
5 document is available within the next 30 A A
days (monocentric) or 45 days
(multicentric). Optional for non-clinical
projects.
6 Investigator's / Project Leader's CV, R R R R R R

dated
Details on infrastructure suitability and
8 availability at the location where the A A
trial is executed
Agreement between
sponsor/commissioned institution /
grant provider or other third parties
and the investigator
9 Regarding trial financing, the allocation of A A A A A A
tasks, the investigator’s compensation
and the publication.
swissethics.ch
1For further use studies involving health-related personal data and/or biological material with consent, a description of the scientific
question is sufficient.

including persons
(Sampling /
Collection)
Document including
including
deceased
be sought

document is available within the next 30
(multicentric).
Insurance
General Insurance Conditions (GIC) for
clinical trials in Human Research (.pdf) in
10 DE, FR, EN and A R
trials (.docx) in DE, FR, IT, EN available at
swissethics.ch
Other documents handed over to study
participants
11 Such as advertisements used in A A
recruitment, patient journals,
study documents, recruitment letters etc.
Details on nature and scope/value of
12 R R A A
compensation for participants
Other personnel
13 Template (.docx) in EN available at A A
swissethics.ch
Information on secure handling of
biological material and personal data,
14 and in particular on the storage thereof R R R R R R
According to art. 18 ClinO (in DE, FR, IT)
and art. 5 ORH (in DE, FR, IT).
Information on reviews of this proposal
15 by other Ethics Committees, or A A A A A A
Regulatory Authorities (Foreign or
Swiss)
Proof of secure and correct coding

30 Please consult Art. 26 (DE, FR, IT) of the R
Human research Ordinance HRO.
Authorizations granted by ethics

committees in Switzerland
31 Any authorizations granted by ethics A
committees in Switzerland for the
sampling of biological material or the
collection of health-related personal data.
Application documents for research
projects involving deceased persons
32 Please provide all further documents as R
listed in Annex 2, chapter 6 of the Human
Research Ordinance HRO. (DE, FR, IT).

including persons
(Sampling /
Collection)
Document including
including
deceased
be sought

projects involving embryos and
foetuses from induced
abortions/spontaneous abortions
33 including stillbirths R
Please provide all further documents as
listed in Annexe 2, chapter 7 of the
Human Research Ordinance HRO (link in
DE, FR, IT).
Table with values of estimated effective
radiation dose
The calculation of the effective dose must
take into account all radiation sources
used in the study and must include the
uncertainty according to Art. 28
34 (DE, FR, IT) Radiological Protection A A
Ordinance from 1994 (Effective Dose +
uncertainty < 5 mSv).
If you don not already have tables with
values of the estimated effective radiation
dose you can download a template of the
table here.
Required authorisation for the use of
ionising radiation according to article
28 of the radiological protection act
35 A A
in DE, FR, IT).
Further documents as listed in Annex
2, chapter 3 of the HRO
36 Provide all further documents as listed in A A
Annex 2, chapter 3 of the Human
Research Ordinance HRO (DE, FR, IT).
Further documents as listed in Annexe
3, chapter 6 of the ClinO
37 Please provide all further documents as A A
listed in Annexe 3, chapter 6 of
the Ordinance on Clinical Trials ClinO (link
in DE, FR, IT).
Sponsor's delegation letter, signed
If the sponsor's representative or the CRO
38 acts as applicant, a delegation letter of the A A A A A A
sponsor is required. If this information is
contained in a contract, please upload this
document.
39 Please only add documents that don't fall A A A A A A
in one of the above categories.

Required documents/information for local sites in multicentric studies.
Document number in BASEC clinical trials non-clinical projects
1 Covering letter optional optional
Synopsis of the study plan in English

or local language
If the synopsis/information about the
A separate synopsis is not required A separate synopsis is not required
synopsis provided on the main upload
for the submission of clinical trials for research projects (HFV, ORH,
screen (screen 6) is neither in English
2 (KlinV, OClin, OSRUm). A synopsis ORUm) if the protocol is shorter
nor in the language of the EC
is generally already included in the than 20 pages.
responsible for this additional site,
protocol. In English or in the local language
please upload a separate version.
available at swissethics.ch.

3 Template for drafting information for adapted to the local site(s) adapted to the local site(s)
participants (.docx) in DE, FR, IT
Signed study plan or signature page

of the study plan
Signed study plan or signature page of
the study plan or protocol, signed and
dated by the local investigator. The signature page signed by local signature page signed by local
4
signature page has to include the title, investigator investigator
version and date of the study
plan/protocol.
Clinical Protocol Template for (.docx) in
EN available at swissethics.ch
Investigator's / Project Leader's CV, CV of the local principal

6 CV of the local project leader
dated investigator
Local investigator's proof of GCP
7 of the local principal investigator -
training
Details on infrastructure suitability
8 and availability at the location where optional optional
the trial is executed
Agreement between
sponsor/commissioned institution
and local investigator
document is available within the next 30
local document/s (upload of drafts local document/s (upload of drafts
9 is acceptable for the first is acceptable for the first
(multicentric).
submission) submission)
Document about trial financing, the
allocation of tasks, the investigator’s
compensation and publication.
swissethics.ch
Insurance
General Insurance Conditions (GIC) for
clinical trials in Human Research (.pdf)
[required only for risk categories B
10 in DE, FR, EN and [required only for risk category B]
& C]
trials (.docx) in DE, FR, IT, EN available
at swissethics.ch

Document number in BASEC clinical trials non-clinical projects
Other documents handed over to

study participants
Such as advertisements used in
11 local document/s (optional) local document/s (optional)
recruitment, patient journals,
study documents, recruitment letters etc.
Other Personnel
Staff list/s when other persons are Staff list/s when other persons are
13 Template (.docx) in EN available at
involved involved
swissethics.ch
other important documents [local
details on further use studies
39 Please only add documents that don't fall other important documents
(description of data/material) can
in one of the above categories.
be uploaded here]

projects involving deceased persons
Please provide all further documents as local document/s (only for projects
32 -
listed in Annex 2, chapter 6, of the involving deceased)
Human Research Ordinance HRO. (Link
in DE, FR, IT).
projects involving embryos and
foetuses from induced
abortions/spontaneous abortions
local document/s (only for projects
33 including stillbirths -
involving embryos and foetuses)
Please provide all further documents as
listed in Annexe 2, chapter 7, of the
Human Research Ordinance HRO (link
in DE, FR, IT).
Table with values of estimated
effective radiation dose
The calculation of the effective dose
must take into account all radiation
sources used in the study and must
include the uncertainty according to Art.
local document/s (if radiation is local document/s (if radiation is
34 28 (DE, FR, IT) Radiological Protection
involved) involved)
Ordinance from 1994 (Effective Dose +
uncertainty < 5 mSv).
If you do not already have tables with
values of the estimated effective
radiation dose you can download a
template of the table here.
Required authorisation for the use of
ionising radiation according to article
local document/s (if radiological local document/s (if radiological
28 of the radiological protection act
35 examinations are involved not examinations are involved not
using standard clinical equipment) using standard clinical equipment)
in DE, FR, IT).
The numbers on the local screen don't necessarily correspond to the numbers in the main document screen
Further use of biological material and/or health-related personal data: please upload the consent
document(s) in field no. 3. If you are unable to obtain a legal consent please upload in the field “Varia”: The
designation of the biological material or health-related personal data of which further use is to be made, the
designation of the group of persons who are to be entitled to pass on the biological material or the health-
related personal data and the designation of the person who is to be entitled to receive the biological material
or the health-related personal data.

Research involving deceased: Also provide the documents in field no. 32

Research involving embryos and foetuses: Also provide the documents in field no. 33
Research involving ionising radiation in any form: Also provide the documents in field no. 34

Antrag Projektfoerderung E

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Antrag Projektfoerderung E

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swissethics Schweizerische Ethikkommissionen für die Forschung am Menschen

Commissions d’éthique suisses relative à la recherche sur l'être humain

Required documents/information for clinical trials

document matrix last update: 09.11.2016 page 1/11

Details on nature and scope/value

Information on secure handling of

Information on reviews of this

document matrix last update: 09.11.2016 page 2/11

Deviation from the prescribing

Information about gene therapy as

Details regarding the information

document matrix last update: 09.11.2016 page 3/11

Proof of the origin & quality of the

Proof of compliance with duties of

Further documents as listed in

document matrix last update: 09.11.2016 page 4/11

Provide all further documents as listed

document matrix last update: 09.11.2016 page 5/11

Required documents/information for non-clinical research projects

6 Investigator's / Project Leader's CV, R R R R R R

document matrix last update: 09.11.2016 page 6/11

Draft acceptable provided the final

Proof of secure and correct coding

Authorizations granted by ethics

document matrix last update: 09.11.2016 page 7/11

Application documents for research

document matrix last update: 09.11.2016 page 8/11

Required documents/information for local sites in multicentric studies.

Document number in BASEC clinical trials non-clinical projects

1 Covering letter optional optional

Synopsis of the study plan in English

Participant information sheet and

Signed study plan or signature page

Investigator's / Project Leader's CV, CV of the local principal

document matrix last update: 09.11.2016 page 9/11

Document number in BASEC clinical trials non-clinical projects

Other documents handed over to

Application documents for research

document matrix last update: 09.11.2016 page 10/11

Research involving deceased: Also provide the documents in field no. 32

document matrix last update: 09.11.2016 page 11/11

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