swissethics – base form for clinical trials

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
Research Project Application Form
Form for clinical trials
(Base Form, Basisformular, Formulaire de base, Modulo di base)
Title:
Date submitted: dd.mm.yyyy
Should be the same as the title of the protocol. Need to be in English for
clinical trials (Art. 3 HFG/LRH)
EC-No.:
SNCTP-No.:
Project-No.:
Public Short title:
100 characters max.
Start Date:
dd.mm.yyyy
End Date:
dd.mm.yyyy
Risk Category: Choose
Acronym:
Mono-/Multi-centric: Please Choose
20 characters max.
Applicant:
Title:
Title
Last Name:
Last Name
First Name:
First Name
(Lead) Ethics Committee: BE
Other ECs involved:
Organization: Organization
Address:
Address
Zip/City:
Zip Code City
Telephone:
Telephone
E-Mail:
Email
BE
EKNZ
GE
SG
TG
TI
VD
VS
Role of Applicant:
What kind of sponsor?:
Please Choose
Please Choose
Who initiated the study?:
Report of Practical Experience?:
Please Choose
Please Choose
ZH
Necessary for education / obtaining a degree?:
Please Choose
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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
Study-Type 1:
Please Choose
Study-Type 2:
Please Choose
Gender of study population: Choose
Allocation:
Please Choose
Target Sample Size:
Blinding techn.:
Please Choose
Type of control:
Please Choose
Phase:
in CH: 000
Choose
total: 000
Minimal/Maximal
age of study subjects:
Arms/distribution: Please Choose
Primary purpose: Please Choose
Vulnerable Population:
adolescents
children
embryo/fetus intrauteri
healthy volunteers
pregnant women
prisoners
emergencies
unable to consent
none
Key inclusion criteria: Free text, 280 characters max.
Key exclusion criteria: Free text, 280 characters max.
Health condition(s) or problem(s) studied:
For instance, type of disease. Free text, 350 characters max.
Intervention(s):
Free text, 700 characters max.
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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
Primary outcome(s)/endpoint(s):
Secondary outcome(s)/endpoint(s):
Free text, 140 characters max.
Free text, 250 characters max.
Countries of recruitment (in addition to Switzerland):
Europe
USA
Asia
Africa
Australia
Countries by name:
Name of Primary Registry:
70 characters max.
Public title in English:
Free text, 200 characters max.
Public title in Swiss national language (de, fr, it):
Free text, 200 characters max.
Information on Financing
Source
Type
Amount in kF(*)
%
Please choose
Please choose
Please choose
Please choose
(*) 1 kF = 1'000 Swiss Francs
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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
Lay summary in Swiss national language (de, fr, or it):
Title:
200 characters max.
Inclusion Criteria:
Exclusion Criteria:
200 characters max.
100 characters max.
Health condition (disease): 50 characters max.
Intervention:
Where in Switzerland can
patients enroll?:
Adress for further
information: Name, phone
number, e-mail address:
100 characters max.
200 characters max.
150 characters max.
Study Decription:
1500 characters max.
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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
Address Page
1a) Address for general queries
4) CRO, Click here if none:
First, last name
First, last name
Address
Address 1
Zip Code
City
Email
Telephone
Zip Code
City
Email
Telephone
5) Address for billing the EC’s fees
1b) for scientific queries
click here if same as 1a):
(postal address in Switzerland mandatory)
First, last name
Choose
Address 1
First, last name
Address 1
Zip Code
City
Email
Zip Code
Telephone
Email
Telephone
2) Principal Investigator (PI, in multicenter
studies: Coordinating Investigator CI)
Click here if same as 1a):
City
6) Local Investigator in multicenter studies
list one per center. click here if same as PI:
a) Name of Center
First, last name
Position, e.g. chief of service
First, Last name
Address 1
Address 1
Zip Code City
Email
Telephone
Zip Code City
Email
Telephone
3a) Sponsor, Click here if same as PI or CI:
b) Name of Center
First, last name
First, Last name
Address 1
Address 1
Zip Code City
Email
Telephone
Zip Code
Email
3b) Sponsor's representative in Switzerland
Click here if same as 3a):
City
Telephone
additional local Invesitgators (use Appendix)
First, last name
Address 1
Zip Code City
Email
Telephone
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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
Signatures
By signing below, you will be reaffirming that you understand your role in this project
and that you agree with this application and its content.
PI (in multicenter studies: CI) Sponsor
CRO, if applicable
Signature
First/Last
Name
Address
Additional documents
Depending on the type of submission, additional documents need to be submitted, see:
http://www.swissethics.ch/templates.html
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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
Appendix
additional local Investigators (One local Investigator per participating center)
c)
Name of Center
First, Last name
Name of Center
First, Last name
Address
Address
City
Zip Code
Email
Telephone
City
Zip Code
Email
Telephone
d)
Name of Center
First, Last name
h)
Name of Center
First, Last name
Address
Address
Zip Code
Email
City
g)
Zip Code
Email
City
Telephone
Telephone
e)
Name of Center
First, Last name
i)
Name of Center
First, Last name
Address
Address
Zip Code
City
Zip Code
City
Email
Email
Telephone
Telephone
f)
Name of Center
First, Last name
j)
Name of Center
First, Last name
Address
Address
Zip Code
Email
Telephone
swissethics.ch
City
Zip Code
Email
City
Telephone
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