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 – Project Plan Template (HRO Art. 6)
(Human research other than clinical trials)
(Project Title)
Project Identifier
This document is the research plan template for research projects involving either humans or data or
biological samples from humans except clinical trials. For clinical trials pursuant to ClinO please refer to
the respective protocol template available at swissethics: Clinical Protocol template for IIT (Investigator
initiated Trials) studies.
This template is suitable for research projects (Note: Definitions are given in the Human Research Act,
HRA Art.3b-i):
- performed in Switzerland and
- where the Swiss law on human research (Federal Act on Research involving Human Beings
(HRA)) and its ordinance HRO (Human Research Ordinance, Ordinance on Human Research
with the Exception of Clinical Trials) applies and
- are human research projects with the exception of clinical trials (HRO Art. 6), e.g. where the
research project does not relate to a project in which persons are prospectively assigned to a
health-related intervention in order to investigate its effects on health or on the structure and
function of the human body (HRA Art. 3l) and
- where:
o (a) biological material is sampled and/or health-related personal data is collected
(prospectively) and/or make further use for research (i.e. for not yet determined research
projects, HRO Art.6) or
o (b) biological material and/or health-related personal data is further used (retrospectively; i.e.
biological material already sampled or data already collected to be used for a research
project, HRO Art. 6, 24ff),
Swissethics strongly recommends using this template when writing plans / study protocols for research
projects meeting these criteria to be submitted to ethics committees and if applicable to Swiss
authorities. The project plan can be submitted in English as well as in the respective local language of
the relevant authority. The template shall be applied correspondingly.
The current template is based on:
- AGEK – CT CER / Swissmedic guidelines: “Studienprotokolle von klinischen‚ Investigatorinitiated’ Studien/Versuchen / Exigences des protocoles d’études/d’essais cliniques initiés par
l’investigateur” dated 24.02.2009,
- the Federal Act on Research involving Human Beings (HRA) and its applicable ordinance
Ordinance on Human Research with the Exception of Clinical Trials (HRO) and
- the STROBE statement
- the Essentials of Good Epidemiological Practice (EGEP)
- swissethics checklists for research project submissions
Note:
 instructions are indicated in blue italics, they need to be deleted (or alternatively may be formatted as
“hidden Text” that will not show in printing).
 Template text formatted in regular type red provide reference to the legal requirements. This text may
be deleted.
 Section headings and template text formatted in regular type (black) should be included in the project
plan document as provided in the template.
 Header and footer should contain the following information (on all pages): [Research Project Title],
[Page x of xx], [version x, DD/MM/YYYY], [Project ID].
 The template needs to be adapted to the individual projects.
 In places where the information is redundant, it is acceptable to refer to another section, to document
or to state its redundancy but the section must not be deleted.
Refer questions regarding use of this research plan template to swissethics (info@swissethics.ch,
phone: +41 (41) 440 26 67, www.swissethics.ch).
Project ID, Version xx of date (DD/MM/YYYY)
page 1 of 18
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
This template was adapted from the template for clinical trial protocols that was developed by a task
force initiated by the Federal Office of Public Health (FOPH) and swissethics (former AGEK) in 2013
and under the lead and coordination of the Swiss Clinical Trial Organisation (SCTO).
Clinical research experts from different institutions reviewed the present template. The FOPH and
swissethics (former AGEK) reviewed the template and recommend its use.
Contributors to this template and reviewers (alphabethic):
- CHUV/PMU Lausanne, Dr Reto Auer
- CHUV/IUMSP Lausanne and Cochrane Switzerland, Dr Bernard Burnand
- CHUV/IUMSP Lausanne and Cochrane Switzerland, Dr Erik von Elm
- EOC Ticino, Dr Stephany Fulda
- EOC Ticino, Dr Liliane Petrini
- HUG/CRC Geneva, Dr Christophe Combescure
- HUG and CCER (Ethics Committee) Geneva, Prof Dr Bernard Hirschel
- Swiss Paraplegic Centre Nottwil, Dr Angela Frotzler
- SAKK and Charité Universitätsmedizin Berlin, PD Dr Pirus Ghadjar
- SCTO Basel, Annette Magnin
- SCTO Basel, Dr Caecilia Schmid
- USZ/CTC Zurich, Dr Eva Brombacher
- USZ Zurich, Dr Cédric Poyet
Project ID, Version xx of date (DD/MM/YYYY)
page 2 of 18
<<Research project template for non interventional
research projects with humans, data or biological
samples from humans>>
Research Plan
The Research Project Plan can be submitted in English or in the respective local language of the relevant
authority.
INSERT TITLE OF THE PROJECT
(HRO Annex 2/1.2; STROBE 1)
Descriptive title identifying the project design (e.g. qualitative research, fundamental research; sampling, etc.),
population (if relevant), project set-up (e.g. multicentre / single centre; national / international) and target
disease(s)/conditions/question.
SHORT TITLE and / or project acronym and / or translation (if relevant; title used in the informed consent form)
Type of Research Project:
State research type:
a) research project in which biological material is sampled from
humans and/or health-related personal data is collected or
b) research project in which already existing biological material and/or
health-related personal data is further used for research
Risk Categorisation:
Provide Risk category: A or B or none according to ordinance HRO
Art.7 (A and B are applicable in case of projects in which material is
sampled and/or data is collected).
Not applicable for research projects using already sampled biological
material or data from humans.
Project Identifier:
If additional identifier applies (e.g. institutional or Sponsor project
number)
Project Leader:
Name of Project Leader (and Sponsor if applicable) responsible for
the research project (Title, Name, Position, full contact details)
Health condition / problem
Health condition or problem to be studied
Project Duration
Planned project period
Project Plan Version and Date:
Version number and date of the document
Add, if applicable, the amendment number, from (date), replaces
version number from (date)
ACCESS TO RESEARCH DOCUMENTS
Add a statement here respecting that it is not in conflict with applicable transparency rules.
Project ID, Version xx of date (DD/MM/YYYY)
page 3 of 18
SIGNATURE PAGE(S)
(swissethics 0, 1a)
Note: Add more lines, functions and pages if relevant, e.g. for project statistician, if relevant or project plan
contributors
Project number
Project Title
Provide if applicable the project identification number (institutional or
sponsor etc.)
Full project title as written out on title page
The project leader and the methodologist (name the respective methodologist, e.g. statistician, clinical
epidemiologist; also name if applicable the local project leaders in multicentre studies) have approved the
research plan version [x (dated DD.MM.YYYY)], and confirm hereby to conduct the project according
to the plan, the current version of the World Medical Association Declaration of Helsinki (name if
applicable the principles to adhere, e.g. Principles of Good Clinical Practice (GCP) or the Essentials of Good
Epidemiological Practice; (EGEP)) and the local legally applicable requirements.
Project Leader:
Printed name of Project Leader (if Sponsor and PL is not the same person please add an additional signature line
for the Sponsor of the project)
Place/Date
Signature
Project Methodologist (name the appropriate methodologist):
Printed name of Methodologist
Place/Date
Project ID, Version xx of date (DD/MM/YYYY)
Signature
page 4 of 18
TABLE OF CONTENTS
SYNOPSIS (SUMMARY) ........................................................................................................................ 6
ABBREVIATIONS ................................................................................................................................... 7
SCHEDULE OF ASSESSMENTS (FLOW OF RESEARCH PROJECT) ............................................... 8
1. ADMINISTRATIVE STRUCTURE ................................................................................................... 9
2. ETHICAL AND REGULATORY ASPECTS .................................................................................. 10
2.1 Ethical Conduct of Study .............................................................................................................. 10
2.2 Risk categorisation ....................................................................................................................... 10
2.3 Ethics Committee (EC) and Competent Authorities (CA), FOPH ................................................ 10
2.4 Participant Information and Informed Consent ............................................................................ 10
2.5 Participant privacy and safety ...................................................................................................... 10
2.6 Early termination of project .......................................................................................................... 11
2.7 Amendments, Changes ................................................................................................................ 11
3. INTRODUCTION............................................................................................................................ 12
3.1 Background .................................................................................................................................. 12
3.2 Rationale for the research project ................................................................................................ 12
3.3 Risk-Benefit Assessment ............................................................................................................. 12
4. OBJECTIVES, ENPOINTS/OUTCOMES AND OTHER STUDY VARIABLES ............................ 12
4.1 Objectives..................................................................................................................................... 12
4.2 Primary and secondary endpoint/outcome(s) .............................................................................. 12
4.3 Other study variables ................................................................................................................... 12
5. PROJECT DESIGN ....................................................................................................................... 13
5.1 Type of research and general project design............................................................................... 13
5.2 Procedures ................................................................................................................................... 13
5.3 Recruitment and Screening.......................................................................................................... 13
5.4 Methods of minimising bias .......................................................................................................... 13
6. PROJECT POPULATION .............................................................................................................. 14
6.1 Inclusion criteria ........................................................................................................................... 14
6.2 Exclusion criteria .......................................................................................................................... 14
6.3 Criteria for withdrawal / discontinuation of participants ................................................................ 14
7. PROJECT ASSESSMENTS .......................................................................................................... 14
7.1 Project flow chart(s) / table of procedures and assessments ...................................................... 14
7.2 Assessments of primary endpoint/outcome ................................................................................. 14
7.3 Assessment of secondary endpoint/outcome(s) .......................................................................... 14
7.4 Assessment of other study variables ........................................................................................... 14
7.5 Assessment of safety and reporting ............................................................................................. 15
7.5.1 Definition of Serious Events (SEs) ...................................................................................... 15
7.5.2 Assessment and Documentation of SEs............................................................................. 15
7.5.3 Reporting of SEs, Safety and Protective Measures ............................................................ 15
8. STATISTICAL METHODOLOGY .................................................................................................. 15
8.1 Determination of Sample Size...................................................................................................... 15
8.2 Data processing ........................................................................................................................... 15
8.3 Planned analysis .......................................................................................................................... 15
8.3.1 Datasets to be analysed ..................................................................................................... 16
8.3.2 Handling of missing data ..................................................................................................... 16
8.3.3 Ancillary analysis ................................................................................................................. 16
8.3.4 Deviations from the original statistical plan ......................................................................... 16
9. DATA AND QUALITY MANAGEMENT ........................................................................................ 16
9.1 Data handling and record keeping / archiving.............................................................................. 16
9.2 Confidentiality, Data Protection .................................................................................................... 16
9.3 Coding .......................................................................................................................................... 16
9.4 Archiving and Destruction ............................................................................................................ 16
10. PUBLICATION AND DISSEMINATION POLICY.......................................................................... 16
10.1 Publication of results ................................................................................................................... 17
10.2 Data sharing ................................................................................................................................ 17
11. FUNDING AND SUPPORT ............................................................................................................ 17
12. INSURANCE .................................................................................................................................. 17
13. REFERENCES ............................................................................................................................... 17
14. APPENDICES ................................................................................................................................ 18
Project ID, Version xx of date (DD/MM/YYYY)
page 5 of 18
SYNOPSIS (SUMMARY)
(HRO Annex 2/1.1)
Provide a structured synopsis (summary) in the national language of the research site (titles shall be translated
accordingly) containing all the important information, preferably in tabular view:
Name of Project Leader or if applicable Sponsor and full contact details
Project Leader (or
Sponsor)
Project Title:
Short Title / Project
ID:
Project Plan Version
and Date:
Risk categorisation:
Type of Research:
Project design:
Background and
Rationale:
Objective(s):
Endpoint(s):
Inclusion / Exclusion
criteria:
Project assessments,
procedures:
Number of
Participants:
Project Duration,
schedule:
Project Centre(s):
Statistical
Considerations:
Other
methodological
Considerations:
Risk-Benefit
statement:
Full title of project.
Short title of project or project ID, if applicable.
The version number and the date of the current research project plan.
Provide Risk category A or B or none according to ordinance HRO Art.7
Research project in which biological material is sampled and/or health-related
personal data is collected or project in which biological material and/or healthrelated personal data is used for further research. Mention whether coded or
uncoded data are used.
Design attributes such as qualitative studies, observational, case-control studies,
cohorts, cross-sectional studies, prevalence studies, etc. or use of routine health
data
Provide a short background and the rationale for the research project, this
includes the health condition / problem studied.
Brief statement of the objectives
Brief statement of the primary and secondary endpoints / outcomes
Brief description of the anticipated project population, the key inclusion and
exclusion criteria and if applicable, the reasons for inclusion of vulnerable
participants.
Describe the research project assessments, measurement, procedures
(methodology, if applicable sampling of biological material).
Number of participants planned for the entire project (e.g. not only for one centre,
rather for entire project, all centres combined). Give the total and the numbers for
each comparison group and the explanation for this sample size, based on a
power analysis if applicable.
Estimated duration for the research project and planned start / end.
Single-centre or multi-centre. If multi-centre, note the number of projected
centres to be involved. If it is a multi-national research project, also list the
participating countries.
A very brief description of the main elements of the statistical methodology to be
used in the project; must include sample size considerations.
If applicable describe here other methodological considerations than statistical,
e.g. epidemiological, qualitative methods.
Short description of risk / benefit assessment. Overall ethical justification of
project, potential benefit of project results.
Project ID, Version xx of date (DD/MM/YYYY)
page 6 of 18
ABBREVIATIONS
Provide a list of abbreviations used in the project plan - to be completed
DoH
EC
EGEP
FOPH
HRA
HRO
ID
IIT
SE
STROBE
Declaration of Helsinki
Ethics Committee
Essentials of Good Epidemiological Practice
Federal Office for Public Health
Federal Act on Research involving Human Beings (Human Research Act, HRA)
Ordinance on Human Research with the Exception of Clinical Trials (Human
Research Ordinance, HRO)
Identification
Investigator-initiated Trial
Serious event
Strengthening the reporting of observational studies in epidemiology
Project ID, Version xx of date (DD/MM/YYYY)
page 7 of 18
SCHEDULE OF ASSESSMENTS (FLOW OF RESEARCH PROJECT)
(STROBE #5, 13c)
Insert if applicable a flow chart (graphic) or tabular listing of schedule of events and assessments and procedures of the project (an example is provided below, amend and expand
according to the specific project).
Project Periods
Screening
Visits (if applicable)
Visit
Time (hour, day, week)
e.g. Participant Information and
Informed Consent
e.g. Demographics
e.g. Medical History
e.g. In- /Exclusion Criteria
e.g Questionnaire (assessment
of …)
1
-xd
x
e.g. any tests to assess
eligibility
x
x
x
x
x
e.g. any tests during study to
assess…
2
0d
3
xd
4
x+/-1d
5
x+/-1d
6
x+/-1d
7
x+/-1d
8
x+/-1d
9
x+/-1d
10
x+/-1d
x
x
x
x
x
x
x
x
x
x
Primary Variables assessment
test or questionnaire or other
method
Secondary Variables
assessment test or
questionnaire or other method
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Sampling of biological material
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Serious (Adverse) Events
Project ID, Version xx of date (DD/MM/YYYY)
Page 8 of 18
1. ADMINISTRATIVE STRUCTURE
(HRO Art. 3, 4, Annex 2/1.8; swissethics 8a, 8b)
Provide the complete contact details (name, title, address, and telephone number) of the qualified Project Leader
(and if applicable of the Sponsor or if applicable the coordinating researcher, the local project leaders at the
project sites in case of a multicentre project, Sponsor representative in CH if applicable) who is responsible for
the conduct of the project.
Provide if applicable the contact details of the qualified statistician, the name of the laboratory, the site of the
storage of health-related personal data and biological material, if applicable name e.g. the project coordination,
data management, or if relevant any other committee (e.g. data monitoring committees, etc.) involved in the
project (reference may be made to a different document, e.g. separate agreement).
Sponsor, Project Leader and Coordinating
researcher (if identical)
to be adapted
Sponsor representative in Switzerland (if
applicable), Project Leader (if different from
Sponsor), Coordinating researcher in case of
multicentre studies (if different from above)
Name: xx
Address: xx
Email: xx
Phone: xx
Fax: xx
or refer to respective form/document
delete word in row above
Project site(s) and responsible researcher:
Institution: xx
Name: xx
Address: xx
Email: xx
Phone: xx
Fax: xx
Key Persons involved in research project:
Name: xx
Address: xx
Email: xx
Phone: xx
Fax: xx
Other personnel
or refer to respective form/document (e.g. staff list to
submit to the EC)
e.g. Biostatistician:
Name: xx
Address: xx
Email: xx
Phone: xx
Fax: xx
e.g. Laboratory:
Institution: xx
Name: xx
Address: xx
Email: xx
Phone: xx
Fax: xx
Other (expand or delete if applicable):
Name: xx
Address: xx
Email: xx
Phone: xx
Fax: xx
Project ID, Version xx of date (DD/MM/YYYY)
Page 9 of 18
2. ETHICAL AND REGULATORY ASPECTS
2.1
Ethical Conduct of Study
(HRA Art. 45-49; HRO, Art. 14, 17-23, Annex 2)
Commencement of this research project is conditional of the documented decision of the EC (and if applicable the
FOPH) concerning the conduct of the project. The research project shall only begin once approval from all
required authorities has been received. Any additional requirements imposed by the authorities shall be
implemented. Provide a statement of seeking the necessary approvals.
e.g. “The research project will be carried out in accordance to the research plan and with principles
enunciated in the current version of the Declaration of Helsinki (DoH), the Essentials of Good
Epidemiological Practice issued by Public Health Schweiz (EGEP), the Swiss Law and Swiss
regulatory authority’s requirements as applicable. The EC and regulatory authorities (FOPH if radiation
sources are involved) will be informed about project start and termination.
2.2
Risk categorisation
(HRO Art. 7, 33)
Describe the risk categorisation of the research project (research involving persons category A or B) and the
rationale for the category (for details see HRO Art. 7).
Projects not involving persons (e.g. further use of biological material and health-related personal data) are
research projects and are not categorised (HRO Art. 33).
2.3
Ethics Committee (EC) and Competent Authorities (CA), FOPH
(HRO Art. 14-23, 34, 37, 41, 45)
Before the project will be conducted, the project plan, the proposed participant information and consent form as
well as other project-specific documents shall be submitted to a competent Ethics Committee (EC).
In case the project includes investigations involving radioactive sources, the opinion from the FOPH is required.
Mention the reporting duties and allowed time frames (all changes in research activity and all unanticipated
problems involving risks to humans; including the case of planned or premature project end and the final report).
Note: The regular end, premature end or interruption of the research project is reported to the EC within 90 days
upon completion of the project (HRO Art. 22). If radiation sources were involved, a final report needs to be sent to
the FOPH within a year.
2.4
Participant Information and Informed Consent
(HRO Art. 8, Annex 2/1.3-1.5)
Explain that participants will be informed about the research project (what, how, by whom) and that consent is
sought from each participant (or if applicable for studies using samples / data that consent has been obtained
earlier); mention of compensation if any are foreseen and that informed consent may be sought for general and
further use of data and/or biological samples.
Describe key aspects regarding the rationale to include particularly vulnerable participants (or refer to relevant
section where they are described, e.g. Chapter 3.3 Risk-benefit assessment) and describe what procedures are
taken, including how to obtain informed consent without delay (see also HRA Art. 21-24, 30, 31).
In the absence of informed consent: Research projects with retrospective data or samples having no participant
consent may only be executed if requirements for exemption as stated in the HRA Art. 34 have been met. The
ethical committee needs to approve the rationale provided in the project plan before issuing an authorisation.
2.5
Participant privacy and safety
(HRA Art. 1, Annex 2/1.7)
The Project Leader affirms and upholds the principle of the participants’ right to dignity, privacy and
health and that the project team shall comply with applicable privacy laws. Especially, anonymity of
the participants shall be guaranteed when presenting the data at scientific meetings or publishing
them in scientific journals.
Individual participant medical information obtained as a result of this research project is considered
confidential and disclosure to third parties is prohibited. Participant confidentiality will be further
ensured by utilising identification code numbers to correspond to medical information in the computer
files.
Project ID, Version xx of date (DD/MM/YYYY)
Page 10 of 18
For data verification purposes, authorised representatives of the Sponsor, a competent authority (e.g.
FOPH), or an ethics committee may require direct access to parts of the medical records relevant to
the project, including participants’ medical history.
2.6
Early termination of project
(HRO Art. 22)
Describe the criteria for the termination of the project or the stopping rules. Provide a statement that the Sponsor,
Project Leader (and any competent authority) may terminate the project prematurely according to certain
circumstances (name the reasons, e.g., insufficient participant recruitment, ethical concerns, financial issues,
change of project leader or any other reason that would prevent the project execution according to the research
plan).
Note: The premature end or interruption of the research project is reported to the EC within 90 days upon
completion of the project (HRO Art. 22). If radiation sources were involved, a final report needs to be sent to the
FOPH within a year.
2.7
Amendments, Changes
(HRO Art. 18, 22, Annex 2)
Significant changes to the project plan must be approved by the EC (amendments, if applicable according HRO
Art. 18). Provide plans for communicating important research plan modifications (e.g., changes to eligibility
criteria, outcomes, analyses) to relevant parties (e.g., investigators, EC, competent authorities).
The Sponsor or Project Leader shall submit to the EC any application documents specified in Annex 2, which are
affected by the change. At the same time, the project leader shall provide information on the reasons for the
change. Substantial amendments are only implemented after approval of the EC.
Project ID, Version xx of date (DD/MM/YYYY)
Page 11 of 18
3. INTRODUCTION
(STROBE 2; HRO Annex 2/1.2)
3.1
Background
Describe the research question, including any scientific data (and if relevant any pre-/clinical evidence) on which
the research project is based (published / unpublished) and including disease background, e.g. distribution in
population, current standard of care (if relevant).
Any statements that rely on existing knowledge or published information shall be adequately referenced.
3.2
Rationale for the research project
Provide a clear statement on the rationale and justification of the research project, potential new findings, and
choice of investigation and the project population. If sampling of materials or collection of data, provide rationale
for creating a biobank or new registry.
3.3
Risk-Benefit Assessment
(HRA Art. 12; HRO Art. 15)
Assess the risk for project participants against the potential benefit (risk-benefit statement). Risk also includes the
risk of unauthorised data access and/or unwanted identification of project participants. Describe key aspects
regarding the rationale to include particularly vulnerable participants (or refer to section where they are described,
e.g. Chapter 2.4 Participant Information and Informed Consent).
For studies without immediate benefit to the project participant, a rationale should be provided stating how the
results of the project could benefit future participants or patients with the same condition/indication due to e.g. a
better understanding of the disease, recovery after surgical procedures, etc.
This also includes a description of how risks to project participants are minimised and if applicable how postproject care and protection is implemented. Note: health-related data protection issues may also be of
importance.
4. OBJECTIVES, ENPOINTS/OUTCOMES AND OTHER STUDY VARIABLES
4.1
Objectives
(STROBE 3)
Describe primary and secondary project objective(s). The primary objective should be clearly marked as such.
Include any prespecified hypotheses if applicable.
4.2
Primary and secondary endpoint/outcome(s)
(STROBE #7)
Describe the primary, secondary, and other endpoint/outcome(s), including the specific measurement variable
(e.g., systolic blood pressure or description of surrogate marker for non-measurable variables), analysis metric
(e.g., change from baseline, final value, time to event), time point for each endpoint/outcome etc.
The primary endpoint/outcome is the main variable that is measured at a precise time-point or at end of the
investigation/observation to answer the primary research question. It should be measurable and should give
information towards the project objective(s)).
Provide a short description of the secondary endpoint/outcome variables and the rationale for the choice of
endpoint/outcomes.
4.3
Other study variables
(STROBE #7)
Describe if applicable other study variables than endpoints, e.g. potential confounders and potential effect
modifiers, exposures, predictors
Project ID, Version xx of date (DD/MM/YYYY)
Page 12 of 18
5. PROJECT DESIGN
(STROBE 4,5, 9; HRO Annex 2/1.2)
5.1
Type of research and general project design
(STROBE 4)
Provide a description of the type of the project (qualitative, observational, fundamental, sampling or collection of
data without research question at present), the project setup (e.g. multicentre / single centre; national /
international).
Describe the design of the research project and the rationale for the choice of design. Provide a discussion of the
known or potential problems and limitations of the design.
5.2
Procedures
(STROBE 5; swissethics 3a)
Provide a description of intended procedures (assessments, measurements, project visits, interviews, etc.) and
stages, the expected duration of participants’ participation, description of the sequence and duration of all
research project periods, refer to schedule of assessment.
For research projects in which biological material is sampled and/or health-related personal data is collected
prospectively: Describe the project duration for each patient, the sequence of all procedures (questionnaires,
project visits, etc.), the permitted timeframe for each visit, the material sampled and stored, as well as methods
and tests used for sample collection and analysis, Describe project-specific procedures (i.e. performed outside
clinical routine) or routine procedures (performed also in clinical routine / daily practice).
For research projects in which already collected biological material and/or health-related personal data is used,
describe the process of data acquisition, including what kind of data is taken and from which source (patient files,
other sources) and what methods / procedures have been used for linkage of data sources. For biological
material, describe what samples are taken, from which source and how they are tested.
For projects without participant consent the following information (if not written elsewhere) needs to be provided
to the Ethical Committee: designation of the group of persons who are to be entitled to pass on the biological
material / health-related personal data, to receive the biological material / health-related personal data, persons
responsible for protection of the data disclosed, group of persons who have access rights for the biological
material / health-related personal data.
5.3
Recruitment and Screening
(swissethics 3b)
Describe procedures for participant recruitment, e.g., “consecutive ongoing recruitment through project leader in
daily clinical practice”, or “participant recruitment through referring physician”, or “participant are contacted by
letter and telephone” or “participant recruitment through advertisement placed in xx”; provide all relevant details
(e.g. such as dates or location).
If applicable, describe screening process and list any screening procedures, such as laboratory or diagnostic
tests necessary to meet in- / exclusion criteria, refer to schedule of assessment.
5.4
Methods of minimising bias
(STROBE 9; swissethics 2)
If applicable, describe any biases that might be encountered during the conduct of your project and measures
taken to reduce them (e.g. recruitment, outcome measurement, data collection, steps to reduce loss to follow up).
Project ID, Version xx of date (DD/MM/YYYY)
Page 13 of 18
6. PROJECT POPULATION
(STROBE 6; HRO Annex 2/1.2)
Describe project population, total number of participants and justification with respect to choice of project
population.
6.1
Inclusion criteria
Describe in detail the inclusion criteria for the participants’ eligibility for the project (if applicable, eligibility criteria
for centres and individuals who will perform the interventions (e.g., surgeons, psychotherapists)). Create a list of
criteria and be as specific as possible.
List all project inclusion criteria, for example: target condition / diagnosis, therapeutic method, surgical
procedure(s), clinical history, age (e.g. age ≥ 18 years), ethnic / sociodemographic background, life style factors
(e.g. exercise, smoking history).
6.2
Exclusion criteria
Describe in detail the exclusion criteria for the participants’ eligibility for the project. Create a list of criteria and be
as specific as possible, for example: pregnant or lactating women, specific medication(s) or treatment(s), other
clinically significant concomitant diseases (e.g. renal failure, hepatic dysfunction, cardiovascular disease, etc.), life
style factors and addictions such as drug or alcohol abuse, inability to follow procedures (e.g. due to
psychological disorders or dementia), insufficient knowledge of project language, etc. (depending on research
project question, additional or other criteria may apply).
6.3
Criteria for withdrawal / discontinuation of participants
Describe reasons for which a participant needs to discontinue from the project, e.g. withdrawal of informed
consent, non-compliance, disease progression, etc. and describe procedures to follow in these cases (e.g. final
examinations, that all biological materials / health-related data is anonymised upon termination of data analysis,
except when the person concerned expressly renounces this right or if anonymisation is not possible and patient
was informed and gave consent at the beginning of the project (HRO Art.10).
7. PROJECT ASSESSMENTS
(STROBE 7; HRO Annex 2/1.2)
Describe procedures, measurements, collection, storage of samples taken, data storage, etc.
7.1
Project flow chart(s) / table of procedures and assessments
Provide a detailed graph, e.g. a flow chart or table ("assessment schedule") describing what is measured and
how, grouped by primary, secondary and/or other endpoints/outcomes. Include the allowed time frames for each
visit. The flow chart should comprise all procedures during the complete course of the project, not only the
assessed endpoints. It may be referred to section “SCHEDULE OF ASSESSMENTS” in case all these details are
provided there.
7.2
Assessments of primary endpoint/outcome
Describe for the primary endpoint/outcome (if applicable) what variables will be assessed/observed and how this
will be done (e.g., questionnaires, laboratory tests), including any related processes (methods) to promote data
quality (e.g., duplicate measurements, training of assessors). Provide a rationale or justification for the use of
certain methods and not others etc. Define the time windows allowed.
7.3
Assessment of secondary endpoint/outcome(s)
Describe the secondary endpoint/outcome parameter(s), e.g. safety, quality of life. Specify the evaluation, at
which time point and how it is assessed or measured (methodology).
7.4
Assessment of other study variables
Describe if applicable how other study variables than endpoints (e.g. potential confounders and potential effect
modifiers, exposures, predictors; demographic or other baseline characteristics) are assessed or measured.
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7.5
Assessment of safety and reporting
(HRO Art. 20. 21)
Describe plans for documentation of safety, serious events and protective measures if applicable for the type of
project. The headings may be deleted if not applicable.
7.5.1
Definition of Serious Events (SEs)
(HRO Art. 21)
A serious event is any unfavourable event for which a causal relationship to sampling of biological
material or the collection of health related personal data cannot be ruled out, and which:
 requires hospitalisation or prolongation of an inpatients’ hospitalisation,
 results in persistent or significant disability or incapacity, or
 is life-threatening or results in death,
If a serious event occurs the research project will be set on hold.
7.5.2
Assessment and Documentation of SEs
(HRO Art. 20, 21)
The assessment by the project leader with regard to the project-specific measure relation is done according to the
following definitions:
Unrelated:
The occurrence of the event has no temporal relationship to the project-specific measures applied
and can be explained by the underlying disease or other factors.
Related:
There is a plausible temporal relationship between the occurrence of the event and the projectspecific, applied measures and cannot be explained by the underlying disease or other factors.
All SEs are to be documented in the participants´ file and on the SE report form. A sample form is appended to
the Protocol and can be downloaded at www.swissethics.ch.
7.5.3
Reporting of SEs, Safety and Protective Measures
(HRO Art. 20)
The project leader shall report any occurring SE to the responsible EC within 7 days (and to the FOPH in case of
involved radioactive sources). He/she shall also submit a report which evaluates the relationship between the
event reported and the methods of collecting health related personal data or sampling of biological material within
that project, furthermore proposals how to proceed with the project.
The project leader shall notify the EC within 7 days of any immediate other safety and protective measures, which
have to be taken during the conduct of the research project. In addition, the project leader shall explain the
circumstances, which necessitated the safety and protective measures.
8. STATISTICAL METHODOLOGY
8.1
Determination of Sample Size
(STROBE 10)
Describe the statistical rationale for sample size in terms of the power of the test to detect a given difference or
attain a given precision in the primary endpoint. If this is not possible, the planned sample size should still be
justified.
8.2
Data processing
Identify any statistical procedures used to modify raw data before analysis (e.g., mathematically transforming
continuous measurements to make distributions closer to the normal distribution, creating ratios or other derived
variables, and collapsing continuous data into categorical data or combining categories).
8.3
Planned analysis
(STROBE 12a-d)
Describe the purpose of the planned analysis and the planned statistical methods for the primary and secondary
endpoints/outcomes and level of significance used (usually two-sided α = 0.05). Describe procedures for reporting
any deviations from the original statistical plan (normally described and justified in the final project report.
Include the statistical software package(s) to be used.
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8.3.1
Datasets to be analysed
Describe the data sets, analysis populations and comparison groups to be used for analysis and methods for any
additional analyses (e.g., subgroup and adjusted analyses).
8.3.2
Handling of missing data
Describe how missing data and data of drop-outs will be handled in the analysis. Ensure that an adequate
number of participants will be evaluated, e.g. by compensating for expected drop-outs or by replacement.
8.3.3
Ancillary analysis
If applicable, describe methods used for any planned ancillary analyses, such as sensitivity analyses, imputation
of missing values, or testing of assumptions underlying methods of analysis.
8.3.4
Deviations from the original statistical plan
Describe how any deviation(s) from the planned analyses will be justified and reported.
9. DATA AND QUALITY MANAGEMENT
(HRO Art. 5, 25-27, Annex 2/1.7)
Describe measures taken for data collection, handling, management and quality control: e.g. that project
personnel is trained on all important project related aspects, that internal audits are planned, quality visits,
independent data review (especially for correct consent and correct data protection), etc.
9.1
Data handling and record keeping / archiving
(HRO Art. 5, 26, 27, Annex 2/1.7)
Describe how data are handled and that all study related documents are archived (essential documents and site
documents).
9.2
Confidentiality, Data Protection
(HRO Art. 5)
Data generation, transmission, storage and analysis of health related personal data and the storage of biological
samples within this project will follow strictly the current Swiss legal requirements for data protection and will be
performed according to the Ordinance HRO Art. 5.
Health related personal data captured during this project and biological samples from participants are strictly
confidential and disclosure to third parties is prohibited; coding will safeguard participants' confidentiality.
Data protection: project data shall be handled with uttermost discretion and only be accessible to authorised
personnel. Include a statement that direct access to source documents will be permitted for purposes of
monitoring, audits or inspections and should declare who will have access to project plan, dataset, statistical
code, etc. during and after the research project (publication, dissemination).
9.3
Coding
(HRO Art. 25-27)
Describe the coding procedures of biological material and/or health-related personal data, the storage location of
the coding key and who has access to the key. The code may only be broken if it is necessary to avert an
immediate risk to the health of the person concerned or to guarantee the rights of the person (e.g. in revoking the
consent) or a legal basis exists for breaking the code.
9.4
Archiving and Destruction
Specify time-period and location of storage of data. If applicable, describe how biological materials will be
destroyed after project termination and how this will be documented or if there is any further use planned, such as
for a biobank, in which case describe planned use and duration.
10. PUBLICATION AND DISSEMINATION POLICY
(HRO Art. 15j; STROBE 22; HRO Annex 2/1.10)
Project ID, Version xx of date (DD/MM/YYYY)
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10.1 Publication of results
Describe plans to communicate project results to participants, healthcare professionals, the public and other
relevant groups (e.g., via publication, reporting in results databases).
10.2 Data sharing
Describe if and how the project data can be accessed by interested third parties e.g. for replication or further
analysis. Give contact details if applicable. Provide information about sharing also in case with third parties with
lower data protection standards than CH or EU.
11. FUNDING AND SUPPORT
(HRO Art. 15j; STROBE 22; HRO Annex 2/1.10)
Provide a brief statement of sources and types of financial, material, and other support for the project. If
applicable, make reference to other places or contracts/documents where this information is captured.
Declare any conflict of interest if applicable and the role of the funders in the research project; otherwise provide a
statement of no conflict of interest (independence, intellectual, financial, proprietary etc.)
12. INSURANCE
(HRO Annex 1; HRO Annex 2/1.6)
Research projects of category B need to document the guarantee of liability (insurance certificate or equivalent
guarantee). It can be referred here to another source where the document has been made available, e.g. in
Appendix or separate document.
13. REFERENCES
Provide a list of the references cited in the project plan.
1. Declaration of Helsinki, Version October 2013,
(http://www.wma.net/en/30publications/10policies/b3/index.html)
2. Essentials of Good Epidemiological Practice (EGEP; http://www.publichealth.ch/logicio/client/publichealth/file/EGEP_en.pdf)
3. Humanforschungsgesetz, HFG Bundesgesetz über die Forschung am Menschen
(Bundesgesetz über die Forschung am Menschen, HFG) vom 30. September 2011/ Loi
fédérale relative à la recherche sur l’être humain (loi relative à la recherche sur l’être humain,
LRH) du 30 septembre 2011.
(http://www.bag.admin.ch/themen/medizin/00701/00702/07558/index.html?lang=de)
4. Verordnung über die Humanforschung mit Ausnahme der klinischen Versuche
(Humanforschungsverordnung, HFV) / Ordonnance relative à la recherche sur l'être humain à
l'exception des essais cliniques (Ordonnance relative à la recherche sur l'être humain, ORH) /
Ordinance on Human Research with the Exception of Clinical Trials (Human Research
Ordinance, HRO) (http://www.admin.ch/opc/en/classified-compilation/20121177/index.html)
5. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, et al. (2007) The Strengthening
the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for
Reporting Observational Studies. PLoS Med 4(10): e296. doi:10.1371/journal.pmed.0040296
6. Vandenbroucke JP, von Elm E, Altman DG, Gøtzsche PC, Mulrow CD, et al. (2007)
Strengthening the Reporting of Observational Studies in Epidemiology (STROBE):
Explanation and Elaboration. PLoS Med 4(10): e297. doi:10.1371/journal.pmed.0040297
7.
Project ID, Version xx of date (DD/MM/YYYY)
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14. APPENDICES
Add any appendices here if relevant. For documents that change very frequently consider mentioning as
separately provided documents with a link included here.
Project ID, Version xx of date (DD/MM/YYYY)
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