Execution
Once the approvals required for your clinical study have been obtained, the practical work on the study can start.
The execution of a clinical study shall follow the documentation approved by the Swedish Ethical Review Authority. Further study approvals may be needed, depending on the study design, see Planning
External link. and Application External link..
Specific laws, regulations and guidelines apply for the execution of clinical studies using medicines and medical devices respectively.
Study participants need to give written consent
In general, a clinical study may only be conducted if the study participants have given their written consent to participate, and prior to this have been informed about what the purpose is and what participation entails. The Swedish Ethical Review Authority may in some cases approve research without written consent, and more information on this is available in Sections 20–22 of the Act concerning the Swedish Ethical Review of Research Involving Humans (SFS 2003:460). The consent shall be voluntary, expressed and defined.
The study participants shall consent to the research to be conducted, to the personal data handling that participation in the study entails, and that any samples are taken and even if they are saved in a biobank.
The consent shall be documented. All study participants have the right to recall their consent at any time with immediate effect, and then also have the right to have samples already taken for the study destroyed or de-identified.
Special rules for consent apply for persons who are under-age and persons incapable of making decisions. The Swedish Ethical Review Authority provides more detailed information on obtaining consent.
Collecting and managing study data
Data shall be collected in a format that can later be analysed, reported and published in a secure way. A data collection form is created based on the approved research plan/protocol, and should be completed in good time before the study begins. Contact your region's IT department for information on secure data management.
For multi-centre studies, it is important to consider the data collection format and to state clearly how data will be generated, by specifying clearly the methods to be used and by defining units and number of decimals, as well as how lack of data shall be registered in order to ensure data is comparable and to facilitate the analysis work. In most cases, the identity of the study participants shall not be shown in the data collection form; instead, names shall be replaced by a unique study code. A list linking the identity of study participants to their unique study codes shall be drawn up in the event it is necessary to link data to patient identity.
What applies for changes to the study protocol after approval?
If you make any significant change to an application that has been approved by the Swedish Ethical Review Authority, you must apply to have this change approved before it is implemented. An application for a change shall describe the planned changed and its purpose. If the change is significant, for example a change to the study design, the study hypothesis or the group of study participants taking part, an entirely new application for ethical review is required. What constitutes a significant change must be determined from case to case.
Please consider
- Has consent been obtained from the study participants?
- Is the study following the research protocol?
- Is the data being handled correctly?
- If the study is an intervention study involving medication or medical devices, special rules apply for documentation, monitoring, and reporting.
Specific rules for medicines and medical devices
There are specific rules to follow for clinical studies of medicinal products or medical devices.
Please note that as of January 31, 2022, a new EU-wide regulation on clinical studies applies. More information is available on the website of the Swedish Medical Products Agency. External link.
Establishing the clinical trial master file
In clinical trials, clinical trial master files should be prepared, one for the sponsorand one for the investigator. The clinical trial master file are established at the initiation of the trial of the medicinal product and are updated on an ongoing basis. The clinical trial master files contain the relevant documentation to initiate a trial of a medicinal product and documentation generated during the course of the trial of the medicinal product. The ICH-GCP provides information on what should be included in the clinical trial master file at the sponsor and the investigator before, during and after completion of the trial. The EMA also has a recommendation for what clinical trial master file should contain. After completion, it should be possible to reconstruct the trial of the medicinal product based on the documentation in the clinical trial master files. The investigator's clinical trial master file contains documentation that is important in their own clinic, and the sponsor’s master filecontains the overall documentation for the entire trial of the medicinal product. Please note that information that could identify study participants must not be included in the sponsor’s clinical trial master file.
Recommendation for what clinical trial master files should contain, EMA website External link.
Conduct of monitoring
Monitoring is conducted for quality control and is a requirement for clinical trials of medicinal products. The monitoring is performed by a monitor on behalf of the sponsor. A monitor must not be involved in the practical conduct of the trial of the medicinal product.
The monitormust have scientific and/or clinical knowledge of:
- regulatory requirements
- ICH-GCP
- the protocol
- the investigational medicinal product being tested
- study participant information
- sponsor procedures.
The monitor will verify that the protocol is followed, that laws and regulations are complied with and that the data collected is complete and correctly recorded.
Notifications in the EU portal for studies conducted under EU Regulation EU 536/2014
The sponsor must notify via the EU portal, e.g., the start date of the trial of the medicinal product, the date of the first study participant's first visit, the end of recruitment, temporary interruptions of the trial and premature termination of the trial. Notifications must be made within 15 days.
Information on notification in the EU portal, EUR-Lex website External link.
Reporting of adverse events
The investigator of a clinical trial of a medicinal product is responsible for continuously recording and in some cases reporting adverse events or abnormal laboratory results. How this will be done should be clearly defined in the trial protocol. As safety reporting is important for both participants in a trial of a medicinal product and for future patients, safety reporting processes must be in place before the trial of the medicinal product starts.
Compiling of an annual safety report
For trials of medicinal products conducted under national legislation and EU Directive 2001/20/EC
For trials of medicinal products conducted under national legislation and EU Directive 2001/20/EC
A safety report summarising serious adverse events is produced annually for clinical trials of medicinal products (Development Safety Update Report, DSUR). The report includes an assessment of safety and that the risk/benefit assessment has not changed during the trial of the medicinal product. The report is sent to the Swedish Medical Products Agency and to the Ethical Review Authority.
For trials of medicinal products conducted under EU Regulation EU 536/2014
A safety report summarising serious adverse events is produced annually for clinical trials of medicinal products. The report includes an assessment of safety and that the risk/benefit assessment has not changed during the trial of the medicinal product. The report is submitted to the EU CTIS database.
Information on annual safety reporting, Swedish Medical Products Agency website External link.
Ensure that all data is complete and accurate
Once data collection in a clinical trial of a medicinal product is completed, the sponsor must ensure that all data recorded during the trial of the medicinal product is complete and accurate. In case of uncertainty, questions are asked to the investigator. Once all the data recorded in the trial database have been checked, supplemented and corrected, the database is declared “clean” (clean file). After that, no changes are made and the statistical analysis of the trial can start.
Reporting of study completion
For trials of medicinal products conducted under national legislation and EU Directive 2001/20/EC
The sponsor must notify the Swedish Medical Products Agency and the Ethical Review Authority** within 90 days that the clinical trial of a medicinal product has been completed. Within one year, a summary of the results of the clinical trial of the medicinal product must then be published in the EU database (EudraCT) and a trial report is prepared.
Information about completed trials, Swedish Medical Products Agency website External link.
For trials of medicinal products conducted under EU Regulation EU 536/2014
The sponsor must notify within 15 days via the EU CTIS portal that the clinical trial is completed in each participating country and when the trial has completed in all participating countries. Within one year, a summary of the trial results must be submitted via the EU portal. In addition to the publication, a written summary of the results must be prepared as well as a layman’s summary.
Medical devices, EU regulation MDR
Medical devices in the EU are divided into two regulatory categories that follow different sets of rules. Medical devices are subject to the EU Medical Devices Regulation (MDR). New rules apply in the EU from May 26, 2021, additional rules apply in Sweden from July 15, 2021.
Recommendation to follow good clinical practice
The clinical trial must not start before an approval from the relevant authorities is in place. Read more about notification and application in the Application section. The study must be conducted in accordance with the clinical investigation plan (CIP) approved by the authorities.
The Medical Products Agency recommends that clinical trials of medical devices be conducted in accordance with ISO 14155:2020 Clinical investigation of medical devices - good clinical practice. The standard includes guidance on roles and responsibilities in a medical device clinical trial; you can read more about this in the Planning step. Through an agreement between the Swedish Standards Institute (SIS) and the Swedish Association of Local Authorities and Regions (SKR), all Swedish healthcare professionals have free access to standards on the SIS website, such as ISO 14155:2020.
Free access to standards, SIS website External link.
Medical device perspectives on consent from study participants
For all clinical studies, unless an exception is approved, study participants must provide informed consent in accordance with the Ethical Review Authority's Guidance on Study Participant Information and Consent. In the case of clinical trials of medical devices, additional requirements for patient information and the consent procedure are specified in the EU Medical Devices Regulation and ISO 14155:2020.
In addition, supplementary Swedish legislation must be followed regarding the consent procedure for clinical trials of medical devices involving minors and incapacitated persons. In the case of a clinical trial of a medical device involving children, both legal guardians must give their informed consent on behalf of the child. Minors over the age of 15, who understand the implications of participating in the trial, must also give their informed consent.
Patient information requirements and consent procedure in ISO 14155:2020, SIS website External link.
Compilation of documentation in clinical trial master files
ISO 14155:2020 provides information on what study documentation should be prepared in a clinical trial of medical devices. A compilation of the documentation should be kept by both the investigator (clinical trial master file, site file) and the sponsor (clinical trial master file, sponsor file). The compilations should contain all the documents necessary to evaluate the conduct and quality of the study. Once a study is completed, it should be possible to reconstruct it based on the documentation in the clinical trial master files. The site file should contain all documentation relevant to the individual trial site and the sponsor file should contain the cumulated documentation for all participating trial sites. Information that could identify study participants must not be included in the sponsor file.
Initiation visit
Prior to the start of the study, the sponsor and/or monitor should conduct initiation visits to all participating sites or hold a single meeting with all principal investigators and staff. The purpose is to review the clinical investigation plan and all study-related activities with the principal investigators and other staff involved in the conduct of the study, and to ensure that the trial site has all the necessary equipment, resources and documentation, including approval, to start the study. It is recommended that the sponsor documents an overview of the meeting content and a list of participants with names, initials, signatures and function. The monitor should write a report of the meeting.
Handling of a medical device in a clinical trial of a medical device
Medical devices and any comparator devices in a medical device clinical trial must be traceable from the time they are sent to the trial site until they are returned or destroyed at the end of the study.
This means, e.g., that the unique identity of the device, the expiry date, the date of receipt by the investigator and the date of return must be documented.
Medical devices evaluated in a medical device clinical trial must be labelled with the phrase “for clinical trialonly”.
The sponsor has overall responsibility for the medical device and for training staff in the use of the device and the documentation required for traceability. The principal investigator ensures that the medical device is used only by authorised users and in accordance with the clinical investigation plan (CIP) and other study instructions.
Safety reporting of product defects and adverse events
In medical device clinical trials of devices that are not yet CE marked or on devices that are not used for their intended purpose, specific safety reporting should be done during the course of the study. This also applies to trials of already CE marked devices used for their intended purpose if serious adverse events related to study-specific procedures occur.
The reporting of adverse events and product failures is important both for the people participating in the study and for future patients. Reporting processes must be in place before the study starts.
The sponsor is responsible for ensuring that all serious adverse events associated with the use of the medical device, a comparator, or the study procedure are reported immediately to the Medical Products Agency during the course of the study. This also applies to device deficiencies that could have led to serious adverse events if appropriate measures had not been taken or if conditions had been less favourable. The safety reporting is summarised at the end of the study and included as part of the study's final report.
Please see the Publish section for more information on writing a final report. External link.
The sponsor has the overall responsibility for safety reporting, but the investigator is responsible for continuously recording and assessing all adverse events and device failures at the trial site. The investigator makes an assessment of the severity and link between the use of the medical device and the adverse event and reports this to the sponsor.
More information on safety reporting and established reporting timelines can be found in the EU Medical Devices Regulation, MDCG 2020-10/1 and ISO14155:2020.
In studies on CE marked devices used within the scope of the intended purpose of the device, the normal procedures of the healthcare system for reporting adverse events and incidents apply. However, an exception applies to serious adverse events related to study-specific procedures, which must also be reported to the Swedish Medical Products Agency in these studies.
Reporting of adverse events and incidents, Swedish Medical Products Agency website External link.
Medical device perspectives on data collection
The case report form (CRF) created on paper or in electronic format during the planning of the study needs to be finalised before the start of the study, see information on the planning page. The people involved in data collection should have received training on how to use the case report form and within what timeframes data should be recorded. The principal investigator of a clinic certifies that the data collected are accurate, complete, legible and recorded in a timely manner.
Information on case report forms (CRF) External link.
Data generated during the study can be recorded directly in the case report form and then constitute source data. Source data can also be generated via, for example, ECG printouts, laboratory analysis reports or recorded for the first time in patients’ medical records or worksheets, and then transferred to the case report form. It is important to define the source data before the start of the study to ensure consistent data management and preservation of all original data.
Verification of source data is an important part of the quality review carried out by the monitor during a study and is also done in case of inspection by authorities.
All study data, including source data, must be stored securely to serve as a reliable reference for the future.
Information on recommendations for data collection in clinical studies of medical devices, including specific recommendations for electronic case report forms, can be found in ISO 14155:2020.
Conduct of monitoring
Monitoring is conducted as a quality control at the participating trial site. The monitor checks that the staff involved in the study have the right qualifications and prerequisites, that the clinical investigation plan (CIP) and applicable laws and regulations are followed, and that data are correctly recorded in the study participants' case report form (CRF). All monitoring activities are documented in a written report to the sponsor.
Monitoring is a requirement for medical device clinical trials and should be done before, during and after the study. The sponsor should establish a monitoring plan before the start of the study. The scope and frequency of monitoring is based on an evaluation of the risks, design and complexity of the study and is described in the monitoring plan. More detailed information on monitoring can be found in ISO 14155:2020.
Monitoring isconducted by a person independent of the investigator and appointed by the sponsor. A monitor must not be involved in the practical implementation of the study.
More on monitor qualifications External link.
Audit and inspection
An audit means that the sponsor or a third party appointed by the sponsor conducts an audit to evaluate compliance with the clinical investigation plan and applicable laws and regulations for study conduct, data management and reporting. An audit can take place at all parties involved in a study and is performed independently of routine monitoring. The reason for an audit varies and may be as part of the sponsor's quality program, as a check on the effectiveness of monitoring, in connection with suspected misconduct, or in preparation for an inspection by an authority.
Information on audits in ISO 14155:2020, SIS website External link.
An inspection is a review by the regulatory authority overlooking the medical device clinical trial and is an official audit and review of study documentation, equipment, resources, records and quality measures at clinics and other parties involved in the study.
The principal investigator is obliged to make study documentation available upon request of the monitor, auditor or inspecting authority.
Amendments to approved application or interruption of ongoing study
If a substantial amendment to an ongoing medical device clinical trial is required, an application for amendment must be submitted to the Swedish Medical Products Agency, which coordinates the review of the amendment with the Ethical Review Authority. No separate amendment application needs to be sent to the Ethical Review Authority, but a special form for ethical review of the change must be sent to the Swedish Medical Products Agency. The application for amendment to the Swedish Medical Products Agency is made via the same electronic process used for the original application.
Application for amendment, Swedish Medical Products Agency website External link.
If the study must be stopped for any reason or an individual trial site must be closed prematurely, this must also be reported to the Swedish Medical Products Agency. The reason for the interruption of the study must be documented and may be, for example, due to suspicion of unacceptable risks to the study participants or serious or repeated non-compliance with the study processes by a trial site. If the study is temporarily suspended or prematurely terminated for safety reasons, the Swedish Medical Products Agency must be notified within 24 hours. If the interruption/termination is for other reasons, this must be reported within 15 days. ISO 14155:2020 further describes the activities that should be performed in case of interruption and premature termination of a study.
Completing a study and preparing for report writing
Once a participating trial site has completed the last study activities and recorded all data in the case report form, the monitormakes a close-out visit. The monitor ensures that all data reporting and documentation is accurate and complete, that any questions have been answered, and that surplus materials or medical devices have been destroyed or returned.
The study sponsor is responsible for ensuring that all close-out activities are performed, checking that all study data are complete and accurate, and making final follow-ups if any ambiguities remain. After that, the study database can be considered final and complete, the database can be locked and the statistical analysis can start.
Guidance on close-out activities at participating sites is provided in ISO 14155:2020.
In vitro diagnostic regulation for medical devices, EU IVDR
Medical devices in the EU are divided into two regulatory categories that follow different sets of rules. In vitro diagnostic medical devices are subject to the EU 2017/746 in vitro diagnostic regulation for medical devices (IVDR). New rules apply within the EU from May 26, 2022.
Recommendation to follow good clinical practice
A clinical performance study cannot start before an approval has been obtained from the relevant authorities. Read more about notification and application in the Application section. The conduct of the study shall follow the clinical performance study protocol approved by the authorities.
The Swedish Medical Products Agency recommends that clinical performance studies of in vitro diagnostic products are performed according to ISO 20916:2019 “good study practice”. The standard provides guidance on roles and responsibilities in a medical device clinical trial. The main text of the standard as well as the annex on adverse event management should be used for all performance studies, while other annexes such as performance study protocol, investigator's brochure, recommended study documentation are not mandatory for performance studies that only require notification to the Swedish Medical Products Agency.
Through an agreement between the Swedish Standards Institute (SIS) and the Swedish Association of Local Authorities and Regions (SKR), all Swedish healthcare professionals have free access to many standards on the SIS website.
Free access to standards, SIS website External link.
Medical device perspectives on consent from study participants
For all clinical studies, unless an exception is approved, study participants must provide informed consent in accordance with the Ethical Review Authority's Guidance on Study Participant Information and Consent. For clinical performance studies, additional requirements for patient information and the consent procedure are specified in the EU Regulation on in vitro diagnostic medical devices and ISO 20916:2019.
In addition, supplementary Swedish legislation must be followed regarding the consent procedure for clinical performance studies involving minors and incapacitated persons.
Compilation of documentation in clinical trial master files
ISO 20916:2019 provides information on what study documentation should be prepared in a clinical performance study. A summary of the documentation should be available at both the trial site conducting the study and the sponsor. The compilations should contain all the documents necessary to evaluate the conduct and quality of the study. Once a study is completed, it should be possible to reconstruct it based on the documentation in the clinical trial master files. The trial site should store all documentation relevant to the individual trial site, and the sponsor should store the compiled documentation for all participating trial sites. Information that could identify study participants must not be stored by the sponsor.
Initiation visit
Prior to the start of the study, the sponsor and/or monitor should conduct initiation visits to all participating sites or hold a single meeting with all principal investigators and staff. The purpose is to review the clinical performance study protocol and all study-related activities with the principal investigators and other staff who will be involved in the conduct of the study, and to ensure that the trial site has all the necessary equipment, resources, training and documentation, including approval, to start the study. It is recommended that the sponsor documents an overview of the meeting content and a list of participants with names, initials, signatures and function. The monitor should write a report of the meeting.
Handling of in vitro diagnostic products in performance studies
In vitro diagnostic devices and any comparator devices in a clinical performance study must be traceable from the time they are shipped to the trial site until they are returned or destroyed at the end of the study.
This means, e.g., that the unique identity of the device, the expiry date, the date of receipt by the investigator and the date of return must be documented.
In vitro diagnostic devices evaluated in a performance study must be labelled with the phrase “for clinical trial only”.
The sponsorhas overall responsibility for the product and for training staff on how to use the product and what documentation is required for traceability. The principal investigator must ensure that the in vitro diagnostic device is used only by authorised users and in accordance with the clinical performance study protocol and other study instructions.
Safety reporting of product defects and adverse events
In clinical performance studies, specific safety reporting during the course of the study is required by IVD legislation. This also applies to performance studies on already CE marked devices used for their intended purpose in case of serious adverse events related to study specific procedures.
The reporting of adverse events and product failures is important both for the people participating in the study and for future patients. Reporting processes must be in place before the study starts.
The sponsor is responsible for ensuring that all serious adverse events associated with the use of the in vitro diagnostic device, a comparator device or the study procedure are reported immediately to the Swedish Medical Products Agency during the course of the study. This also applies to device deficiencies that could have led to serious adverse events if appropriate measures had not been taken or if conditions had been less favourable. The safety reporting is summarised at the end of the study and included as part of the study's final report.
Information on writing a final report External link.
The sponsor has the overall responsibility for safety reporting, but the investigator is responsible for continuously recording and assessing all adverse events and device failures at the trial site. The investigator makes an assessment of the severity and link between the use of the medical device and the adverse event and reports this to the sponsor.
More information on safety reporting and established reporting timelines can be found in the EU Regulation on in vitro diagnostic medical devices and ISO 20916:2019.
In clinical performance studies of CE marked devices used within the scope of the intended purpose of the device, the normal healthcare procedures for reporting adverse events and incidents apply. However, an exception applies to serious adverse events related to study-specific procedures, which must also be reported to the Swedish Medical Products Agency in these studies.
Reporting of adverse events and incidents, Swedish Medical Products Agency website External link.
Medical device perspectives on data collection
The case report form (CRF) created on paper or in electronic format during the planning of the study needs to be finalised before the start of the study, see information on the planning page. The people involved in data collection should have received training on how to use the case report form and within what timeframes data should be recorded. The principal investigator of a clinic certifies that the data collected are accurate, complete, legible and recorded in a timely manner.
Information on case report forms (CRF) External link.
Data generated during the study can be recorded directly in the case report form and then constitute source data. Source data can also be generated via, for example, ECG printouts, laboratory analysis reports or recorded for the first time in patients’ medical records or worksheets, and then transferred to the case report form. It is important to define the source data before the start of the study to ensure consistent data management and preservation of all original data.
Verification of source data is an important part of the quality review carried out by the monitor during a study and is also done in case of inspection by authorities.
All study data, including source data, must be stored securely to serve as a reliable reference for the future.
Information on recommendations for data collection in clinical performance studies including specific recommendations for electronic case report forms can be found in ISO 20916:2019.
Conduct of monitoring
Monitoring is conducted as a quality control at the participating trial site. The monitor checks that the staff involved in the study have the right qualifications and prerequisites, that the clinical performance study protocol and applicable laws and regulations are followed, and that data are correctly collected and recorded. All monitoring activities are documented in a written report to the sponsor.
Monitoring is a requirement for clinical performance studies and should be done before, during and after the study. The sponsor should establish a monitoring plan before the start of the study. The scope and frequency of monitoring is based on an evaluation of the risks, design and complexity of the study and is described in the monitoring plan. More detailed information on monitoring can be found in ISO 20916:2019.
Monitoring isconducted by a person independent of the investigator and appointed by the sponsor. A monitor must not be involved in the practical implementation of the study.
More on monitor qualifications External link.
Audit and inspection
An audit means that the sponsor or a third party appointed by the sponsor conducts a review to evaluate compliance with the clinical performance study protocol and applicable laws and regulations for study conduct, data management and reporting. An audit can take place at all parties involved in a study and is performed independently of routine monitoring. The reason for an audit varies and may be as part of the sponsor’s quality program, as a check on the effectiveness of monitoring, in connection with suspected misconduct, or in preparation for an inspection by an authority. For more information on audits, see ISO 20916:2019
An inspection is a review by the regulatory authority overlooking the clinical performance study and is an official audit and review of study documentation, equipment, resources, records and quality measures at clinics and other parties involved in the study.
The principal investigator is obliged to make study documentation available upon request of the monitor, auditor or inspecting authority.
Amendments to approved application or interruption of ongoing study
If a substantial amendment to an ongoing clinical performance study is required, an application for amendment must be submitted to the Swedish Medical Products Agency, which coordinates the review of the amendment with the Ethical Review Authority. The application for amendment to the Swedish Medical Products Agency is made via the same electronic process used for the original application.
Application for amendment, Swedish Medical Products Agency website. External link.
If the study must be stopped for any reason or an individual trial site must be closed prematurely, this must also be reported to the Swedish Medical Products Agency. The reason for the interruption of the study must be documented and may be, for example, due to suspicion of unacceptable risks to the study participants or serious or repeated non-compliance with the study processes by a trial site. If the study is temporarily suspended or prematurely terminated for safety reasons, the Swedish Medical Products Agency must be notified within 24 hours. If the interruption/termination is for other reasons, this must be reported within 15 days. ISO 20916:2019 further describes the activities that should be performed in case of interruption and premature termination of a study.
Completing a study and preparing for report writing
Once a participating trial site has completed the last study activities and recorded all data, the monitormakes a close-out visit. The monitor ensures that all data reporting and documentation is accurate and complete, that any queries have been answered and that any surplus material or in vitro diagnostic products have been destroyed or returned.
The study sponsor is responsible for ensuring that all close-out activities are performed, checking that all study data are complete and accurate, and making final follow-ups if any ambiguities remain. After that, the study database can be considered final and complete, the database can be locked and the statistical analysis can start.
Guidance on close-out activities at participating trial sitesis provided in ISO 20916:2019.
Links and related information
Links
Obtaining consent and support template, Ethical Review Authority website External link.
Amendment application, Ethical Review Authority website External link.
Links - medicines
Clinical trial master file recommendations and study report guidelines, EMA website. External link.
Registration in the EU portal, EUR-Lex website External link.
Annual safety reporting, Swedish Medical Products Agency website. External link.
Templates for planning and implementing monitoring External link.
Links - medical technology
Standards, SIS website. External link.
Information on writing a final report External link.
Guidance on safety reporting in clinical investigations (MDGC 2020-10/1) External link., European Commission website
Reporting of adverse events and incidents, Swedish Medical Products Agency website External link.
Qualifications of the monitor External link.
Application for amendment, Swedish Medical Products Agency website. External link.
ATMP (Advanced therapy medicinal products)
Advanced therapy medicinal products (ATMP) are human medicines, based on genes, tissues or human cells. They offer ground-breaking new opportunities for the treatment of diseases and injuries. More information about advanced therapy:
For guide/templates and regulatory guide, ATMP project website External link.
Classifications, regulatory information, European Medicines Agency website External link.
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