Planning
Once the research problem has been defined, you can begin planning your clinical study. The planning stage includes developing a research plan, preparing information and insurance coverage for study participants, and drawing up a study budget.
- Start planning your clinical study
- Choose the study design and methods
- Plan data collection, data management and storage
- Develop a research plan
- Develop a Statistical Analysis Plan
- Prepare information for study participants
- Ensure insurance coverage for study participants
- Plan resources, funding and the budget
- Consider a health economic evaluation
- Use templates and supporting documents
- Specific requirements for medicinal products and medical devices
- Planning a clinical trial of a medicinal product
- Planning a clinical investigation of a medical device
- Planning a performance study of an in vitro diagnostic medical device
- Related information about Advanced therapy medicinal products (ATMPs)
- Advanced therapy medicinal products (ATMPs)
Start planning your clinical study
Once you have defined the research problem and know which questions need to be answered, you can begin planning your clinical study.
You can receive guidance during the planning process from the regional nodes within Clinical Studies Sweden. If you are a researcher at a university or other higher education institution, you may also be able to receive support from specialists at your institution.
Contact your regional node for support during the planning process
Choose the study design and methods
The research question determines which study design and methods are appropriate. These choices affect which data need to be collected, how the results can be analysed and which conclusions can be drawn.
The study design and methods of analysis need to be planned together. You should therefore consult a statistician at an early stage of the planning process.
Guidance on scientific quality
The Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) systematically evaluates methods used in healthcare. SBU has published a handbook providing guidance on the scientific assessment of different study designs.
Handbook on study designs, SBU website External link.
Guidance from ICH
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has developed guidance documents for planning clinical trials of medicinal products. The documents may also be useful when planning other types of interventional studies.
- ICH E9 Statistical Principles for Clinical Trials, ICH website External link.
- ICH E10 Choice of Control Group and Related Issues in Clinical Trials, ICH website External link.
ICH E9 and E10 include information about:
- blinding
- choice of control group
- the difference between confirmatory and exploratory objectives
- the importance of outcome measures.
Plan data collection, data management and storage
Once you have determined which data need to be collected to answer the research question, you also need to decide how the data will be collected.
Structure data collection using a CRF or eCRF
A common way to structure data collection is to create a data collection tool known as a Case Report Form (CRF).
The tool may take the form of:
- a paper-based form, CRF
- an electronic system, eCRF, which often forms the basis of a database used for analysis.
Data collected using a paper-based CRF must subsequently be transferred to an electronic format. An eCRF generates electronic data directly.
A CRF consists of questions or checkboxes completed by study staff when the study participant:
- answers questions
- undergoes examinations that generate measurements.
Information from the participant’s medical records may also be documented in a CRF.
Label and identify data
You need to plan how the collected data and materials will be labelled with identifiers. This may apply to:
- completed CRFs
- questionnaires
- samples
- images
- register data.
A unique number is often used for each study participant to prevent data from being confused.
You also need to decide whether a link between the collected information and the study participant’s identity will remain after data collection has been completed. If the link is to be retained, the general rule is that the data must be labelled so that only someone with access to a code key can identify the person who provided the information.
Develop a data management plan
A clear data management plan describes how data will be collected and labelled and who will have access to them.
The plan makes it easier to describe the data management procedures to study participants, regulatory authorities, data protection officers and other parties that need information during the conduct of the study.
Develop a research plan
Clinical studies conducted in Sweden require approval from the Swedish Ethical Review Authority. A complete and detailed research plan, also referred to as a research protocol, must be enclosed with the ethical review application.
The research protocol may also form the basis of applications to other regulatory authorities. Specific requirements for medicinal products and medical devices are described further down this page.
The protocol serves as a manual intended to ensure that:
- everyone involved can conduct the study consistently
- it is possible to determine retrospectively how the study data were generated.
The research plan or research protocol must contain:
- the scientific research question and the specific objectives and purpose of the project
- an overview of previous research results in the field
- a project description covering the study design, selection of study participants, sample size calculation, procedures and methods
- definitions of primary and secondary outcome variables
- a brief description of the study’s significance to the field of research
The section Specific requirements for medicinal products and medical devices provides information about specific requirements for research plans and trial protocols.
Develop a Statistical Analysis Plan
For open-label studies, a Statistical Analysis Plan (SAP) must be in place before the study begins. For blinded studies, the plan must be in place before the database is locked.
A Statistical Analysis Plan must contain:
- detailed definitions of the analysis populations
- analysis variables
- a general description of the analyses
- the exact analysis methods for each analysis variable
Further information about statistical analyses is available in the Analysis chapter.
Prepare information for study participants
Before a person consents to participate in a clinical study, they must be given access to all the information that a person may reasonably need to decide whether to participate.
The information must be designed to comply with the information requirements of the Swedish Biobank Act and the General Data Protection Regulation. Biobank Sweden has compiled information that must be provided to study participants about biobank samples.
If the study is to be reviewed by the Swedish Medical Products Agency, additional requirements apply to the information provided to study participants. These requirements are described under Specific requirements for medicinal products and medical devices further down this page.
Ensure insurance coverage for study participants
Before the study begins, the research principal needs to determine which insurance coverage applies to the study participants and whether supplementary insurance is required.
The insurance coverage that applies to the study must be specified in the application to the Swedish Ethical Review Authority. The applicable coverage may depend on:
- who the research principal is
- where the study is conducted
- the type of study
- the procedures to which participants will be exposed
Specific insurance requirements may apply to clinical trials of medicinal products and clinical investigations of medical devices. Further information is available below.
Plan resources, funding and the budget
Before the study begins, you need to ensure that sufficient time, staff, expertise and financial resources are available to conduct and complete it.
The study budget must cover all anticipated costs. Depending on the study design, you may need to budget for:
- staff
- training
- applications and fees
- agreements
- data collection and data management
- programming and validation of computerised systems
- investigational medicinal products or medical devices
- control or comparator products
- laboratory analyses and other examinations
- biobank management
- insurance
- compensation for study participants
- statistical support and analysis
- monitoring and other quality control
- archiving
- publication and administration.
The budget should be reviewed regularly during the conduct of the study.
Funding is available from Swedish and international research funding bodies. Researchers may also apply for grants and scholarships through healthcare regions, universities and other organisations.
Consider a health economic evaluation
Consider at an early stage whether the study should include a health economic evaluation.
Such an evaluation investigates whether a medical intervention is cost-effective, meaning whether there is a reasonable relationship between its costs and effects. Effects may be measured in terms of improved health and increased Health-Related Quality of Life (HRQoL).
Use templates and supporting documents
Clinical Studies Sweden provides templates and supporting documents that can be used when planning and conducting clinical studies.
These include:
- protocol templates
- templates for information to study subjects
- checklists
- support for monitoring and quality assurance.
Points to consider during the planning stage
When planning your study, you need to clarify how it will be conducted, what resources are required and how the study data will be managed.
- Is the research plan complete?
- Have participant information, informed consent and insurance been prepared?
- If biological samples will be used, has the relevant biobank been contacted?
- Is there a complete study budget?
- Does the study need to be registered in a public database?
- Have data collection, management and storage been planned?
- Does the study involve a medicinal product or medical device that is subject to specific requirements?
Specific requirements for medicinal products and medical devices
If you are planning a clinical study involving a medicinal product or medical device, specific regulations and processes apply. Under the relevant headings below, you will find information about what to consider during the planning stage.
Contact your regional node within Clinical Studies Sweden if you are unsure which regulations apply or need support in planning and preparing your study.
Planning a clinical trial of a medicinal product
Authorisation and trial protocol
A clinical trial of a medicinal product requires authorisation from the Swedish Medical Products Agency. Guidance on the agency’s website can help you determine whether your study constitutes a clinical trial and therefore requires authorisation.
A trial protocol must be included in the application. It provides the basis for conducting the trial consistently across all participating trial sites and must contain the information needed to conduct the trial correctly.
Requirements for the content of the trial protocol are set out in Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use.
A trial protocol template with supporting guidance is available on this website.
- Find out whether your study requires authorisation, Swedish Medical Products Agency's website External link.
- Documents required when applying for a clinical trial of a medicinal product, the website of the Swedish Medical Products Agency External link.
- Trial protocol template with supporting guidance External link.
Roles and responsibilities under ICH-GCP
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for clinical trials of medicinal products. It sets out requirements for how trials are designed, conducted, documented and reported. The purpose of GCP is to:
- protect the rights, safety and well-being of trial subjects
- ensure that the data generated by the trial are reliable
Under ICH-GCP, Regulation (EU) No 536/2014 and applicable national legislation, roles and responsibilities must be allocated before the trial begins.
- ICH-GCP, International Council for Harmonisation website External link.
- Clinical Trials Regulation (EU) No 536/2014 and national legislation, European Medicines Agency website External link.
The sponsor
The sponsor is the person, company, institution or organisation responsible for initiating and organising the trial and arranging its funding.
In some cases, the same individual may be both the sponsor and the principal investigator. That individual then assumes the obligations associated with both roles.
Sponsor responsibilites
The sponsor has overall responsibility for the conduct of the trial. This includes ensuring that:
- all required regulatory authorisations are in place before the trial begins
- written procedures for trial conduct, quality control and quality assurance are available
- the procedures are followed
- trial subjects are provided with financial protection through insurance or other means
The sponsor may delegate some or all of their tasks to an individual, company, institution or organisation. However, the sponsor retains overall responsibility for ensuring that the trial is conducted and reported in accordance with the applicable authorisations and regulations.
Checklist for sponsor responsibility (in Swedish) External link.
Risk assesment
Under ICH-GCP, the sponsor must assess the risks associated with the clinical trial. Based on the assessment, the sponsor determines:
- which risks need to be managed
- how quality control should be carried out.
Further information is available in the ICH Good Clinical Practice guideline E6.
- Risk analysis template (in Swedish) External link.
- ICH Efficacy Guidelines, International Council for Harmonisation website External link.
The monitor
The monitor is appointed by the sponsor and oversees the progress of the clinical trial.
Monitor responsibilites
The monitor’s responsibilities include:
- ensuring on-site that the trial of the medicinal product is conducted, documented and reported in accordance with the protocol, GCP and applicable regulatory requirements
- submitting a written report to the sponsor after each site visit
- reporting other relevant communications concerning the trial to the sponsor
Competence and independence
In order for the monitor to be able to supervise a trial of a medicinal product, in addition to having prior scientific and/or clinical knowledge, he or she needs to have knowledge of:
- the product to be tested
- the protocol
- Sponsor procedures
- GCP
- regulatory requirements
The monitor must be independent of the conduct of the trial at the trial site.
The investigator
The investigator must have the education, training and experience needed to assume responsibility for conducting the trial and protecting the health and safety of trial subjects. This includes documented training in GCP.
A qualified medical doctor or dentist must be responsible for medical decisions relating to the trial.
Investigator responsibilites
The investigator must:
- demonstrate that it is possible to recruit the agreed number of trial subjects
- allocate sufficient time to conduct and complete the trial
- appoint appropriately qualified staff to assist with the trial
- supervise all delegated tasks
- ensure that delegated staff receive appropriate training
- ensure that subjects receive the required information and provide informed consent in accordance with applicable requirements
- establish procedures for storing trial documentation
- allow monitoring and auditing
Checklist for investigator responsibility (in Swedish) External link.
Delegation
The investigator has overall responsibility for the trial at the trial site but may delegate individual tasks.
Delegation must be documented in writing in a signature and delegation log. The log must be kept up to date when members of the trial team change.
A task must be delegated before it is performed by someone other than the investigator. The investigator remains responsible for supervising delegated tasks.
Principal investigator
If more than one investigator works at a trial site, the sponsor may appoint one of them as the principal investigator.
Data management and archiving
Case Report Forms
Data about trial subjects are collected using a Case Report Form (CRF). The CRF may be paper-based or electronic.
An electronic Case Report Form (eCRF) may form the basis of the database used for analysis. Data collected using paper CRFs must subsequently be transferred to an electronic format.
Data management and validation plans
Plans for data management and data validation must be established. These may take the form of:
- a Data Management Plan (DMP)
- a Data Validation Plan (DVP)
Archiving trial documentation
Trial documentation must be stored securely and remain complete and readable for at least 25 years after the clinical trial has been completed and reported.
Planning a clinical investigation of a medical device
Clinical investigations of medical devices are governed by the EU Medical Devices Regulation (EU) 2017/745 (MDR), which came into effect on 26 May 2021.
Study design and research question
The research question and study design may vary depending on the purpose of the study and the medical device’s stage of development.
ISO 14155:2026, Annex I, provides information about different study designs and statistical considerations for clinical investigations of medical devices. You can also find information about study design in the Analysis chapter.
In addition to the scientific considerations, it is important to ensure that the chosen research approach is ethically and practically feasible. You should also consider how the study design may affect data quality.
Complex study designs may require extensive training for users and study staff or detailed monitoring strategies to reduce the risk of compromised data quality. A design that more closely reflects routine healthcare practice may present fewer practical challenges.
- Formulating a research question or hypothesis, Idea page
- Standard ISO 14155:2020, SIS website External link.
- Study design and statistical aspects, Analysis page
Clinical Investigation Plan and information for study subjects
The study protocol for a clinical investigation of a medical device is called a Clinical Investigation Plan (CIP).
The requirements for the content of a CIP are more extensive than the Swedish Ethical Review Authority’s requirements for a research plan. The MDR and ISO 14155:2026 provide detailed information about what the CIP must contain.
In addition to the Swedish Ethical Review Authority’s requirements for the written information provided to study subjects, the MDR and ISO 14155:2026 contain specific recommendations about the information that must be provided to subjects in a clinical investigation of a medical device.
- Medical Devices Regulation (EU) 2017/745 External link.
- ISO 14155:2026, Swedish Institute for Standards website External link.
- Templates and supporting documents
Roles and responsibilities
Under the MDR and ISO 14155:2026, distinct roles and responsibilities must be assigned when planning and conducting a clinical investigation of a medical device.
The manufacturer
The manufacturer is the person, company or institution responsible for:
- designing and manufacturing the medical device
- labelling and packaging the device
- preparing the instructions for use
- specifying the device’s intended purpose
The manufacturer may apply to place the device on the market under their own name. The manufacturer is responsible for CE marking the device, regardless of who carries out its physical production.
The sponsor
The sponsor is the individual or organisation responsible for initiating and conducting the clinical investigation.
The sponsor and manufacturer are often the same individual or organisation, but they do not have to be.
The sponsor has overall responsibility for the clinical investigation, including:
- planning and conducting the investigation
- communicating with regulatory authorities
- quality assurance and quality control
- tasks and functions carried out by subcontractors
A complete description of the sponsor’s role and responsibilities is available in ISO 14155:2026.
The principal investigator
The principal investigator is responsible for conducting the clinical investigation at an investigational site. If an investigation is conducted at several investigational sites, there must be a responsible investigator at each site.
The principal investigator must have documented training and experience in the area in which the medical device will be used. The required competence must be assessed in relation to the device’s intended area of use.
The principal investigator has overall responsibility for the investigation at the investigational site. Tasks may be delegated to members of the study team if the delegation is documented in writing and the person receiving the task has appropriate training and experience.
The principal investigator’s responsibilities include:
- leading the investigation at the investigational site
- ensuring that informed consent is obtained from subjects in accordance with applicable regulations and the Clinical Investigation Plan
- ensuring that the investigation is conducted according to the Clinical Investigation Plan
- ensuring that subjects receive the necessary medical care during and after their participation
- conducting safety reporting
- ensuring that reliable data are generated
A complete description of the principal investigator’s role and responsibilities is available in ISO 14155:2026.
Monitor
The monitor is appointed by the sponsor and is responsible for independently verifying that the clinical investigation is conducted in accordance with the Clinical Investigation Plan and applicable regulatory requirements.
The monitor carries out site visits to:
- review how the investigation is being conducted
- assess compliance with the Clinical Investigation Plan and applicable requirements
- provide feedback to the study team about any corrective or preventive measures that are needed.
After each visit, the monitor submits a written report to the sponsor.
The monitor needs scientific or clinical knowledge relevant to the research area. The monitor must also be familiar with:
- ISO 14155:2026
- the device being investigated and how it is used
- the Clinical Investigation Plan
- approved procedures for obtaining informed consent
- the sponsor’s policies and manuals
- any other relevant regulatory requirements
A complete description of the monitor’s role and responsibilities is available in ISO 14155:2026.
Insurance for study subjects
The sponsor of a clinical investigation of a medical device must guarantee, through insurance or by other means, that participants can receive compensation if this becomes necessary because of actions taken by the sponsor or investigator.
The sponsor must determine:
- what insurance coverage is available to study subjects
- whether supplementary insurance is needed
Subjects in clinical investigations conducted within region-funded healthcare are covered by the Swedish patient insurance scheme, Löf. Healthcare providers that are not covered by this regional patient insurance must arrange their own insurance.
Product liability insurance with supplementary coverage for clinical investigations may also be required to cover other types of damage. This may include:
- injury to an employee or family member handling the investigational device
- damage to the device
- damage to other property
Notification or application to the Swedish Medical Products Agency
Research that qualifies as a clinical investigation of a medical device must either be notified to the Swedish Medical Products Agency or submitted to the agency for approval.
Detailed information about the authorisation process is available on the Swedish Medical Products Agency’s website and on the Application page of this website.
- Applications and notifications, Swedish Medical Products Agency's website External link.
- Application, Application page
Data collection, data management and electronic systems
Every clinical investigation of a medical device must use a tool for collecting data. This may be a paper form or an electronic system and is referred to as a Case Report Form (CRF). Annex C to ISO 14155:2026 provides an example of what a CRF can contain.
ISO 14155:2026, Swedish Institute for Standards' website External link.
Electronic and paper case report forms
An electronic Case Report Form (eCRF) can serve as the primary source for creating the study database. Data collected using paper CRFs must subsequently be transferred to an electronic format.
When an eCRF is used, the system must meet specific requirements concerning functionality and data security. In particular, it must include an audit trail that:
- records all changes made to entered data
- identifies the person responsible for each change.
The requirements for electronic systems used in clinical investigations of medical devices are specified in ISO 14155:2026.
Processing personal data
The sponsor is responsible for ensuring that sensitive personal data are processed in accordance with applicable data protection regulations.
This includes determining whether the electronic system involves processing personal data:
- outside the country
- within an organisation other than the sponsor
The CRF must correspond to the Clinical Investigation Plan
All data collected in the CRF must be described in the Clinical Investigation Plan. The plan must be approved by both the Swedish Ethical Review Authority and the Swedish Medical Products Agency. No other data may be collected.
Medical devices for in vitro diagnostics (IVDR)
Planning a performance study of an in vitro diagnostic medical device
Performance studies of in vitro diagnostic medical devices are governed by the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which came into effect on 26 May 2022.
Study design and research question
The design of a performance study is based on the research question or hypothesis to be answered or tested.
The research question and study design may vary depending on the purpose of the study and the IVD device’s stage of development.
Performance studies of IVD devices aim to determine or confirm the analytical or clinical performance of a device. Clinical performance studies are intended to determine or confirm aspects of the device’s performance that cannot be established through:
- analytical performance studies
- scientific literature
- previous experience from routine diagnostic testing.
When planning a clinical performance study, it is important to ensure that the scientifically optimal approach is also ethically justified and practically feasible. You should also consider how the study design may affect data quality.
Complex study designs may require extensive training for users and study staff or detailed monitoring strategies to reduce the risk of compromised data quality. A design that more closely reflects routine healthcare practice may present fewer practical challenges.
- Formulating a research question or hypothesis, Idea chapter
- ISO 20916:2024, Swedish Institute for Standards website External link.
- Study design and statistical considerations, Analysis chapter
Clinical Performance Study Plan and information for study subjects
The study protocol for a clinical performance study of an IVD device is called a Clinical Performance Study Plan (CPSP), also referred to as a clinical performance study protocol.
The requirements for the content of a CPSP are more extensive than the Swedish Ethical Review Authority’s requirements for a research plan. The IVDR and ISO 20916:2024 provide detailed information about what the plan should contain.
In addition to the Swedish Ethical Review Authority’s requirements for written participant information, the IVDR and ISO 20916:2024 contain specific recommendations about the information that should be provided to participants in a clinical performance study.
- In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 External link.
- ISO 20916:2024, Swedish Institute for Standard website External link.
Roles and responsibilities
Under the IVDR and ISO 20916:2024, distinct roles and responsibilities must be assigned when planning and conducting a performance study of an IVD device.
The manufacturer
The manufacturer is the person, company or institution responsible for:
- designing and manufacturing the IVD device
- labelling and packaging the device
- preparing the instructions for use
- specifying the device’s intended purpose.
The manufacturer may apply to place the device on the market under their own name. The manufacturer is responsible for CE marking the device, regardless of who carries out its physical production.
The sponsor
The sponsor is the individual or organisation responsible for initiating and conducting the performance study.
The sponsor and manufacturer are often the same individual or organisation, but they do not have to be.
The sponsor has overall responsibility for the performance study, including:
- planning and conducting the study
- communicating with regulatory authorities
- quality assurance and quality control
- tasks and functions carried out by subcontractors
A complete description of the sponsor’s role and responsibilities is available in ISO 20916:2024.
The principal investigator
The principal investigator is responsible for conducting the performance study at an investigational site. If the study is conducted at several investigational sites, there must be a responsible investigator at each site.
The principal investigator must have documented training and experience in the area in which the IVD device will be used. The required competence must be assessed in relation to the device’s intended area of use.
The principal investigator has overall responsibility for the study at the investigational site. Tasks may be delegated to members of the study team if the delegation is documented in writing and the person receiving the task has appropriate training and experience.
The principal investigator’s responsibilities include:
- leading the study at the investigational site
- ensuring that informed consent is obtained from subjects in accordance with applicable regulations and the Clinical Performance Study Plan
- ensuring that the study is conducted according to the Clinical Performance Study Plan
- ensuring that subjects receive the necessary medical care during and after their participation
- conducting safety reporting
- ensuring that reliable data are generated.
A complete description of the principal investigator’s role and responsibilities is available in ISO 20916:2024.
The monitor
The monitor is appointed by the sponsor and is responsible for independently verifying that the clinical performance study is conducted in accordance with the Clinical Performance Study Plan and applicable regulatory requirements.
The monitor carries out site visits to:
- review how the study is being conducted
- assess compliance with the Clinical Performance Study Plan and applicable requirements
- provide feedback to the study team about any corrective or preventive measures that are needed.
After each visit, the monitor submits a written report to the sponsor.
The monitor needs scientific or clinical knowledge relevant to the research area. The monitor must also be familiar with:
- ISO 20916:2024
- the device being studied and how it is used
- the Clinical Performance Study Plan
- approved procedures for obtaining informed consent
- the sponsor’s policies and manuals
- any other relevant regulatory requirements.
A complete description of the monitor’s role and responsibilities is available in ISO 20916:2024.
Insurance for study subjects
The sponsor of a performance study of an IVD device must guarantee, through insurance or by other means, that study subjects can receive compensation if this becomes necessary because of actions taken by the sponsor or investigator.
The sponsor must determine:
- what insurance coverage is available to subjects
- whether supplementary insurance is needed
Subjects in performance studies conducted within region-funded healthcare are covered by the Swedish patient insurance scheme, Löf. Healthcare providers that are not covered by this regional patient insurance must arrange their own insurance.
Product liability insurance with supplementary coverage for performance studies may also be required to cover other types of damage. This may include:
- injury to an employee or family member handling the investigational device
- damage to the device
- damage to other property
Notification or application to the Swedish Medical Products Agency
Certain types of performance studies require either a notification or an application for authorisation to the Swedish Medical Products Agency. These include studies of companion diagnostics and studies in which participants are exposed to additional interventions or risks.
Detailed information about the notification and authorisation processes is available on the Swedish Medical Products Agency’s website and on the Application page of this website.
- Performance studies of IVD devices, Swedish Medical Products Agency's website External link.
- Application and notification information for clinical performance studies, Application chapter External link.
Data collection, data management and electronic systems
Every performance study must use a tool for collecting data. This may be:
- a paper form
- an electronic system
- a printout from a measuring instrument
Electronic Case Report Forms
When an electronic Case Report Form (eCRF) is used, the system must meet specific requirements concerning functionality and data security.
In particular, the system must include an audit trail that:
- records all changes made to entered data
- identifies the person responsible for each change
Processing personal data
The sponsor is responsible for ensuring that sensitive personal data are processed in accordance with applicable data protection regulations.
This includes determining whether the electronic system involves processing personal data:
- outside the country
- within an organisation other than the sponsor
The CRF must correspond to the Clinical Performance Study Plan
All data collected in the CRF must be described in the Clinical Performance Study Plan. The plan must be approved by both the Swedish Ethical Review Authority and the Swedish Medical Products Agency. No other data may be collected.
ISO 20916:2024, Swedish Institute for Standards's website External link.
Related information about Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs) are biological medicinal products based on genes, cells or tissue engineering. ATMPs are regulated by common EU legislation supplemented by Swedish legislation.
The links below provide further information, regulatory guidance, templates and training.
- Advanced therapy medicinal products, Swedish Medical Products Agency website External link.
- Guides, templates and regulatory support, ATMP Sweden website External link.
- ATMP classification and regulatory information, European Medicines Agency website External link.
- Online course: Introduction to advanced therapies, Swedish Academy of Pharmaceutical Sciences website External link.
Research support for clinical trials involving advanced therapy medicinal products
Contact your regional node within Clinical Studies Sweden to find out what research support is available for your study.
Contact your regional node within Clinical Studies Sweden External link.
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