List of documents to be submitted for notification of clinical investigations of medical devices. 

The documents must be submitted as separate files. There are help documents for several of the sub-points, follow the link: 

01.01 Cover letter 

01.02 Application form 

1. The relevant form can be found here 

02.01 Investigators Brochure 

02.02 Instructions for use 

02.03 Checklist for fulfilment of general safety performance requirements 

03.01 Clinical Investigation plan 

1. An international test plan must be supplemented with Danish special requirements in an addendum if the international test plan does not comply with Danish law. The appendix must refer to the original project title and have the date and version number 

04.01 Participant information sheet 

04.02 Informed consent form 

05.01 Copy of conformity assessment if the equipment is not CE marked 

06.01 Sponsors statement on how to comply with GDPR 

07.01 Danish synopsis 

08.01 Questionnaires (possibly in one single file) (if more than one document, assign each document with a number, e.g. 08.01, 08.02, etc.) 

09.01 Recruitment material 

E.g. advertisements, posts, recruitment letters, text on www.sundhed.dk or social media 

10.01 Documentation of insurance if the Danish Patient Compensation does not cover 

See also. Guidance on insurance. 

11.01 Danish version of relevant parts of the sponsorship contract  

About publication conditions and possible fees for researchers/research participants and researchers' access to data 

12.01 Documentation for CE marking 

13.01 Documentation of the investigators' experience, education and identity (for all investigators at all Danish sites (if more than one document, assign each document with a number, e.g. 13.01, 13.02, etc.) – NB! Only one responsible per site 

1. CV 
2. Authorization ID (extract from the authorization register) 
3. Copy of health card, driver's license or passport. If necessary, the last 4 digits of the social security number can be crossed out 

14.01 Proof of the identity of the sponsor (if more than one document, assign each document with a number, e.g. 14.01, 14.02, etc.) 

1. The company's address and CVR no.
2. Contact person 
3. If the sponsor is located outside the EU (with the exception of Norway, Iceland, Liechtenstein and Turkey), information about the EU-appointed representative's address and CVR number must be provided. 

15.01 Billing Information 

1. Link to form 
2. The invoicing form must be signed and attached to the application at the same time as submission 

Your record must include the following information: 
 

1. Original title of the investigation
   
   
2. Description and classification of all and only the devices being investigated
   
   
3. Information on the manufacturer, alternatively the EU authorized representative and the importers
   
   
4. Purpose
   1. Purpose and reason for conducting the investigation, including whether the test takes place within the boundaries of the device's CE marking. For equipment that is not CE marked, it must be stated whether the purpose of the investigation is to obtain a CE marking.   
   2. Brief literature review and bibliography 
   3. If a previous investigation is being replicated it must be explained why. 

5. Method
   1. A description of the investigation design and methodology, including a description of any control groups and randomization.
   2. An explanation of the practical details of the investigation and how it is to be conducted. 
   3. Specify if and how algorithms are part of the device being tested. 
   4. Start and duration of the test 

6. Endpoints
   1. Describe and justify the endpoints of the experiment 

7. Statistical considerations
   1. Power calculation or other statistical calculation justifying the number of participants. 
   2. Describe and justify the study's effect size (or any margin of non-inferiority) 
   3. Describe how data is analyzed (e.g. by intention-to-treat, per protocol, etc.) 

8. The investigation participants
   1. Inclusion criteria 
   2. Exclusion criteria 

9. Risks and side or adverse effects, both in the long and short term
   1. Including safety measures that minimize pain, discomfort, fear and other risks 

10. Monitoring plan

The monitoring plan must be aligned with the risks of the investigation and any deviations from normal clinical practice. This applies to both the scope and character of the plan. 

Describe: 

1. Who is responsible for monitoring the investigation
2. The qualifications of the monitor 
3. The activities performed for monitoring purposes 

Examples of relevant factors could be: 

• Data quality (e.g. correct transfer of data from source documents) 
• Consent process (e.g. approved version of participant information, correct translations) 
• Handling the devices (e.g. compliance with the Investigator's Brochure, proper labeling of the devices) 
• Unintentional occurrences (e.g. correct and timely reporting) 
• Laboratory tests (e.g. storage of samples, use of labels) 
• The statistical analysis (e.g. identification of missing data, large fluctuations between centres) 

11. Extraction of new biological material or collection of biological material from already existing biobank

Describe: 

1. What and how much material 
2. What purpose 
3. Whether the material is destroyed after analysis.  
   If the material is stored in a research biobank (i.e. beyond 5-7 days from collection) 
   
   See the Biobank Guidelines, section 5.2: 
   
   
4. How long and what is the purpose of storage? If the project material is sent abroad: 
5. Which country and what purpose 
6. That the General Data Protection Regulation and the Data Protection Act are complied with. In the case of transfers to third countries, please provide additional information on how Chapter V of the General Data Protection Regulation is complied with. If there is biological material in surplus after the end of the project 
   See Biobank Guidelines, section 5.2.2: 
7. Whether the material is destroyed or completely anonymized, or 
8. Whether the material will be stored for future research and that the data protection rules continue to be complied with.  
   If additional material is also taken for future non-specific research: 
9. This is not the committee's area of authority, but is regulated by the General Data Protection Regulation and the Data Protection Act. However, it may be stated in the protocol that the participants will be asked separately about this in order to subsequently be able to document that the material in the biobank has been extracted in connection with the specific research project. 
   If project material is imported: 
10. Submit documentation/declaration from the company/institution that the material has been extracted/collected in an ethically responsible manner in accordance with the legislation at the place of collection and legally carried out by the country 

12. Information from patient records
    
    If information from the patient records is to be used for the project, the following must be described: 
    1. It must be clear what information is needed and what the information is to be used for. A distinction must be made between information that is to be used before the participants have consented to participation, e.g. in connection with identification/recruitment, and the information that is to be used for the project after consent to participation has been given 
    2. It must be stated that the information that is to be used in the project before consent has been given by the investigation participants is given to the researcher 
    3. It must be stated that the consent gives the investigator, sponsor and sponsor's representatives, as well as any control authority, direct access to obtain information in the participant's medical records, etc., including electronic medical records, in order to see information about the investigation participant’s health conditions that is necessary as part of the implementation of the research project and for control purposes, including self-monitoring, quality control and monitoring, which they are obliged to carry out 

13. Processing of personal data in the project
    1. You must clearly state you intend to comply with the General Data Protection Regulation and the Data Protection Act. Please note that it is the responsibility of the sponsor or the person responsible for the investigation to ensure that all investigation activities are in compliance with the data protection rules concerning the processing of personal data. There may be requirements in the local health authority (Regionerne) or at the university to register the project on an internal register. 
    2. If personal data is sent abroad, you must describe to which country and for which purpose. 
    3. How you intent to comply with the General Data Protection Regulation (including Chapter V) in the event of data being transferred to third countries. 

14. Economy
    1. Describe who has taken the initiative for the investigation
       
       If there are donors, describe: 
       
       
    2. Name of donors, including amount for each donor (fixed sum and/or per investigation participant) 
    3. How the financial donation is given to the investigation, such as remuneration of staff, laboratory tests etc. Please attach any budget you may have. 
    4. Whether the support is paid directly to the researcher, his/her department/institute, research foundation or other (for researchers in RVK Syddanmark, the account number to which the support amount is included must be stated) 
    5. Whether any responsible research staff has any financial connection to or interest in the funding provider or other stakeholders in the investigation. 

15. Any remuneration and/or other benefits to the investigation participants
    
    See also Appendix 1: Guidelines for remuneration and other benefits to volunteer investigation participants. 
    
    
    1. The amount of the remuneration, including any transport allowance, lost earnings and/or inconvenience allowance 
    2. How much the will participants be paid proportionately if they withdraw early 
    3. Other valuable goods given as part of the investigation. 
    4. For investigation patients, you must explain that the requirements in Appendix 1 are met 

16. Recruitment of investigation participants and informed consent
    
    See also the standard Guidelines for the provision of oral participant information 
    Describe the recruitment and the procedure for oral information and receipt of the consent: 
    
    
    1. How the investigation participants are recruited (posting, advertisement, recruitment letter, internet, social media or via medical records) 
    2. How the first contact with the investigation participant takes place 
    3. The process of obtaining informed consent 
       1. Where, when and by whom the oral and written information is provided 
       2. How to ensure that the conversation takes place undisturbed 
       3. How the right to an assessor is secured in practice 
       4. What is the reflection period between the provision of oral and written information and the obtaining of informed consent? 
       5. When consent is sought 

17. Publication of results
    1. Describe where results are subsequently made publicly available 

18. Section on research ethics
    
    Describe:
     
    1. Why the risks are not justifiable in themselves or in relation to the benefits of the test, and 
    2. Why the therapeutic benefit for the participant or future patients justifies the investigation

19. Information about compensation scheme
    1. Whether the test is covered by Danish Participant Compensation (Patienterstatningen) or whether an independent insurance policy is provided by the sponsor. 

You must submit a Danish summary of the protocol, i.e. a synopsis, which must be a true and comprehensive description that can be understood by people without health professional training. It must be generally understandable Danish, where clinical terms are explained or paraphrased. NB: there may only be information in the Danish summary that is included in the other project material (such as the test plan or participant information). 

1. Original title of the clinical investigation plan 
   
   
2. Name and study site of the investigator/sponsor 
   
   
3. Purpose of the investigation
   
   
4. The method, design and research procedures of the investigation, including information about any research biobank 
   
   
5. Investigation participants, including inclusion and exclusion criteria 
   
   
6. Side effects, risks and disadvantages 
   
   
7. Economic conditions 
   
   
8. Recruitment of investigation participants 
   Same requirements as for protocol item 12 
   
   
9. Publication of the results of the investigation
   
   
10. Research ethics report 

The date and version number must be added to the document and each time changes are made.  
The written participant information must describe the following: 

1. Original title of the investigation
   
   
2. Request to participate in a clinical investigation
   
   
3. Purpose and significance of the investigation, as well as the scope of activities for the individual participant 
   
   
4. Method and practical organisation of the investigation
   
   
5. Risks, disadvantages and stresses of the investigation
   
   1. The foreseeable risks, side effects, complications, disadvantages and strains in the short or long term – including radiation risks – and their expected frequency 
   2. Possible safety measures 
   3. It must be stated that there may be unforeseen risks and strains associated with the testing. 
      
      
6. What is the standard treatment and are there other options for treatment? 
   
   
7. Journal information 
    
   If information from the patient record is to be used for the project, the participant information must state: 
   
   
   1. Which information is to be used and its purpose 
      
      
   2. That the participant’s consent gives the investigator, sponsor and his/her representative direct access to relevant health information in the medical record in order to conduct and monitor the study 
      
      
8. Processing of personal data 
   1. Describe that personal data will be processed in the investigation. Please state that the Data Protection Act and the General Data Protection Regulation are complied with. (Please note the duty of disclosure (about the data subjects’ rights) that applies under the General Data Protection Regulation, see the Danish Data Protection Agency's guidance on this) 
      
      
9. Extraction of biological material from investigation participants 
   
   See also Guidelines on the use of biological material in health science research projects. 
   
   Describe: 
   1. Which material and how much material is taken out 
   2. What the purpose of extracting biological material is 
   3. Whether the material is destroyed after analysis 
   4. Or whether the material is stored in a research biobank (i.e. storage beyond 57 days after it has been extracted): 
   5. How long the material is stored 
   6. What the purpose of the storage is 
       
      If the material is sent abroad, state: 
      
      1. Which country and for what purpose? 
   7. That the General Data Protection Regulation and the Data Protection Act are complied with. In the case of transfers to third countries, please provide additional information on how Chapter V of the General Data Protection Regulation is complied with 
      If there is any surplus biological material at the end of the project, please state: 
   8. Whether the material is destroyed or completely anonymized, or 
   9. Whether the material will be stored for future research, and if so, that the data protection rules will continue to apply. It must be stated that new research on the biological material must be approved by the research ethics committee and that, as a general rule, new consent must be obtained, but that the committee can grant exemptions (see section 5.2.2 of the biobank guidelines) 
      
      
10. Usefulness of the investigation
    1. Describe the potential benefits for the investigation participant as well as for others with the same condition and future research. 
       
       
11. Interruption of investigation participation 
    1. Describe what could lead to the investigation participant being removed from the investigation population. 
       
       
12. Any remuneration and/or other benefits to the investigation participant 
    Describe: 
    1. The amount of the remuneration given to participants, including remuneration for transport, lost earnings and/or inconvenience. 
    2. How much will the participants be paid proportionately if they withdraw early? 
    3. Any other goods. 
    4. Taxation 
       
       
13. Economy 
    Describe:  
    1. Who initiated the investigation? 
    2. Names of donors 
    3. Who is supporting the investigation – the amount for each donor, and how the support is included in the investigation
    4. Whether the person responsible for the investigation has financial ties to companies or foundations with an interest in the investigation.
       
       
14. Contact person 
    
    1. An explanation of where the participant can obtain more information if they wish so 
    2. Name, address, email address and telephone number of a person responsible for the investigation
       
       
15. Publication of results 
    1. Describe where participants can subsequently find information about the results of the experiment in an accessible format 
       
       
16. General rights of the investigation participants 
    1. You must enter (or attach) the information that appears here. 

Investigator brochure (IB) shall contain clinical and non-clinical information on the device intended for testing in question that is relevant to the investigation and which is available at the time of application. 

The purpose of the IB is to provide the investigator and other persons involved in the investigation with guidance and a clear understanding of the possible risks and side effects of the investigation, as well as what specific tests, observations and safety measures are necessary during the conduct of the investigation. 

The IB must be clearly identifiable and in particular contain the following information: 

1. Front page with the following information 
   1. Sponsor's Name 
   2. Medical devices intended for testing 
   3. Version number 
   4. The release date of the IB 
   5. Reference to the version that the current IB replaces 
      
      
2. Statement 
   1. If the sponsor wants the Investigator to treat the IB as a confidential document only for use by the Investigator team and authorities. 
      
      
3. Table of contents 
   
   
4. Summary 
   
   
5. Introduction 
   
   1. A brief introduction of which devices are included in the investigation, the rationale for the testing of the medical devices and the expected use afterwards. 
      
      
6. Description of the medical devices under investigation 
   1. Identification and description of the devices: including information on the declared purpose, risk class and applicable classification according to Annex VIII of the Medical Device Regulation (MDR), the design and manufacture of the device, and reference to previous and similar generations of the device. 
   2. The manufacturer's instructions for installation, maintenance, maintenance of hygiene standards and use, including requirements for storage and handling, and the extent to which such information is available, information to be included on the label, and instructions for use to be supplied with the devices when it is placed on the market. In addition, information on any relevant required training for handling the devices. 
   3. For devices incorporating a medicinal product, including a human blood or plasma derivative, or devices manufactured using non-viable tissues or cells of human or animal origin or of derivatives thereof, detailed information on the medicinal product or on the tissues, cells or derivatives thereof, and on compliance with the relevant general safety and performance requirements and specific risk management measures in relation to the substance or tissues,  cells or their derivatives, as well as evidence of the added value of the incorporation of such constituents in relation to the clinical benefits and/or safety of the device. 
   4. A list indicating that the relevant general safety and performance requirements set out in Annex I, including the standards and common specifications used, have been fully or partially complied with, as well as a description of the solutions used to meet the relevant general safety and performance requirements, insofar as those standards and common specifications have not been or have only been partially complied with or are missing. 
      
      
7. Non-clinical studies 
   1. Preclinical evaluation on the basis of relevant preclinical testing and study data, in particular regarding design calculations, in vitro tests, ex vivo tests, animal tests, mechanical or electrical tests, reliability tests, sterilisation validation, software verification and validation, performance testing, biocompatibility evaluation and biological safety, if applicable 
      
      
8. Clinical investigations
   
   1. Existing clinical data from: 
      1. relevant available scientific literature describing the safety, performance, clinical benefit to patients, design characteristics and stated purpose of the device and/or similar or similar device; 
      2. other relevant available clinical data describing the safety, performance, clinical benefits to patients, design characteristics and stated purpose of similar or similar devices from the same manufacturer, including how long it has been on the market, and a review of performance, clinical benefit and safety issues and any corrective actions; 
         
         
9. Summary of data and guidance for the investigator 
   1. Summary of the analysis of the benefit/risk balance, including information on known or foreseeable risks, possible side effects, contraindications and warnings. 
   2. A detailed description of the clinical procedures and diagnostic tests used during the clinical investigation, in particular information on any deviation from normal clinical practice. 

1. Research with children 
   The test plan is supplemented with the following:  
   1. Scientifically justify why it is necessary to conduct the experiment on children. 
   2. Specifically justify that the investigation has a reasonable potential for direct gain to the participant that outweighs any risks or burdens associated with the investigation
   3. Describe the age of the children and justify the choice of age group concretely, as older children should be included rather than smaller children 
   4. Describe any measures that can minimize pain, fear or discomfort in relation to the child's development 
   5. The procedures for information and consent must be supplemented by the following: 
      1. Indicate that consent will be obtained from both parents in the case of joint custody. See also the declarations of consent 
      2. What prerequisites the informing healthcare professional has, i.e. knowledge of the area and pedagogical prerequisites for informing the age group 
      3. How the information to the child will be adapted to the child's ability to understand the experiment, its age and maturity (from 5 years and up, written information must be provided) 
      4. That independent consent will be obtained from the young person when the young person reaches the age of majority, in the case of young investigation participants who reach the age of majority in the investigation
   6. In particular, in less intrusive attempts, where permission has been sought for the young person to give consent independently, you must: 
      1. explain that it is a 15-17-year-old who is not exposed to intervention or other forms of stress, e.g. swab experiments, and 
      2. state that the holder of custody receives the same information as the young person and is involved in the decision on the investigation. 
         
         
2. Research with adults incapacitated (incompetent) 
   See also Guidelines on informed and proxy consent in health science research projects, section 3. 
   The test plan is supplemented with the following: 
   
   1. Explain why the investigation participant are incapable of acting (unable to take care of their own affairs) 
   2. Scientifically justify why it is necessary to conduct the investigation with disqualified participants. 
   3. Specifically justify that the investigation has a reasonable potential for direct gain to the participant that outweighs any risks or burdens associated with the investigation 
   4. The procedures for information and consent shall be supplemented by information on: 
      
      1. That proxy consent will be obtained from the next of kin and the investigation guardian. See also the declarations of consent 
      2. What prerequisites the informing healthcare professional has for involving the investigation participant 
      3. That the information provided to the investigation participant is adapted to their ability to understand the study  
      4. That written participant information has been prepared for the deputy 
      5. How the investigation guardian is appointed – he or she must use his or her professional knowledge to assess whether the investigation participant in question can participate in a investigation of this nature. See section 3.4 of the Guidance on informed and proxy consent. 
      6. That an independent consent will be obtained from the investigation participant if he/she regains his/her impartiality in the investigation. This only applies to experiments that have a character where impartiality can be regained. 
         
         
3. Research with pregnant or breastfeeding women 
   The test plan is supplemented with the following: 
   1. Scientifically justify why it is necessary to conduct the investigation with pregnant or breastfeeding women 
   2. Specifically justify that the investigation has a reasonable potential for direct gain to either the participant, embryo, fetus or child, outweighing any risks or burdens associated with the investigation 
   3. Explain if breastfeeding women are included in the investigation that special consideration is given to the child's welfare 
      
      
4. Research in emergency situations 
   The test plan is supplemented with the following: 
   1. Scientifically justify why it is necessary to carry out the experiment in an emergency situation. 
   2. Specifically justify that the investigation contains a reasonable potential for direct gain to the participant, which can provide a measurable health benefit. 
   3. Explain that the investigation involves only minimal risks and burdens compared to standard treatment. 
   4. Procedures for consent and information are supplemented with the following:  
      1. Explain that the investigation participant is unable to receive information and give consent in advance due to sudden illness or life-threatening condition. 
      2. Explain that consent will be obtained without undue delay from the investigation participant (if possible) or his/her legally appointed representative. 
      3. Explain that consent is obtained from the investigation participant without undue delay as soon as possible. 
      4. Explain that it is not possible to provide information in advance and obtain prior proxy consent from the investigations participant’s legally appointed representative. 
      5. Explain that the investigation coordinator is not aware that participants in the investigation have previously asked not to participate. 
      6. Describe how the investigation guardian is appointed – he or she must use his or her professional knowledge to assess whether the investigation participant in question can participate in a investigation of this character. See section 3.4 of the Guidance on informed and proxy consent. 

If it is a comprehensive mapping of the genome, the following must be described. For other genome projects, where there may also be a risk of significant health findings, the committee will also be able to apply the same principles in the assessment, e.g. in the case of targeted examination of a very large number of genes. The checklist for research in biological material applies in parallel with the below. Describe: 

1. Examination methods 
   
   1. That it is a matter of comprehensive mapping of the genome 
   2. Which part of the genome (e.g. gene panels, exomers, whole genome, epigenome, RNA) and what type of sequences are being studied (rare and/or frequent variants, structural variants, etc.) See the list of methods here: 
   3. Which sequencing platform or high-density array is used, as well as sequencing depth. 
   4. Which bioinformatics tools are used. 
      
      
2. Data Retention 
   1. How data is stored, including where and for how long. 
      
      
3. Reporting of incidental findings 
   
   1. If it is a study with a risk of mutation in high-penetrant genes: That the investigation participant will receive genetic counselling prior to the research 
   2. How you assess the probability of incidental findings. Justify this. Handling of the participants’ requests for feedback. Both about the genes that are being studied and about incidental findings. The genome guide must be followed if incidental findings occur 
   3. That a group of independent experts will be set up to assess incidental findings and advise on how to deal with them 
   4. If you also use this method to minimize the likelihood of incidental findings, then focus only on specific areas of the genome and disregard other areas that may deal with clinically relevant genes, e.g. the genes on the ACMG's list. In such a case, it must be stated that the filtering of these nuisances is done in such a way that no data is generated or registered regarding the unwanted information. See The Genome Guide and use the formulations from this one. 
      
      
4. Possible research collaborations 
   See The Genome Guide.  
   Describe 
   1. Name of the business partner 
   2. What the collaboration is about: 
      1. laboratory analyses, including bioinformatic analyses, if any: Describe that a data processing agreement is entered into in this regard (see the Danish Data Protection Agency) 
      2. If there is (possibly supplementary) research collaboration: Describe that the external party may only conduct research within the purpose of the protocol and is aware of the 5 criteria regarding the duty to provide feedback in the Genome Guide. 
   3. What data is given access to (and is it in coded form, for example?) 
   4. Whether genomic data is transferred abroad 
   5. That the personal data from the sequencing is processed in accordance with the rules of the General Data Protection Regulation and the Data Protection Act as well as in accordance with the principles of the Health Act for relatives. 
      
      
5. Participant information in genomics  
   A standard declaration of consent and a declaration of opt-out of knowledge have been prepared. If you do not use the standard, the information should include the following: 
   
   1. Explain that this is a comprehensive mapping of the investigation participant’s genetic material and explain the purpose. Describe: 
       
      The method in short (whole genome examination or exome sequencing etc.) 
      1. What knowledge you expect to gain 
      2. Whether the participant will benefit from the study and if so, what 
      3. If it is a study with a risk of mutations in high-penetrant genes: State that the participants receive genetic counselling prior to the research 
      4. If genome data is stored after the experiment: That the storage takes place in accordance with the General Data Protection Regulation and the Data Protection Act 
      5. If you have a research collaboration with domestic or foreign collaborators. Please state: 
         1. Name of the business partner 
         2. What the collaboration is about 
         3. What data is given access to (e.g. is it in coded form?) 
         4. Whether genomic data is transferred abroad 
         5. That the personal data from the sequencing is processed in accordance with the rules of the General Data Protection Regulation and the Data Protection Act. 
            
            
6. Feedback on health findings 
   Describe: 
   1. That knowledge can emerge that was not foreseen (încidental findings) 
   2. That the investigation participant will be informed in the rare situations where a genetic variation is detected that may cause serious disease that can be prevented or treated 
   3. That it may also be appropriate to inform family members if the information can prevent death or serious deterioration of health 
   4. That the investigation participant can request not to receive information about incidental findings, but that the investigation participant must contact the researcher separately (Declaration on opt-out of knowledge). 
   5. How the investigation participant can get information about the outcome of the study. 
      
      
7. Genomic research in biological material without consent 
   1. There must be a detailed reason for not obtaining consent from the investigation participants. Describe the risk of getting random findings and how these will be handled. See The Genome Guidance. 
   2. The same conditions must be explained as in Research on biological material with exemption from consent. See also here. 
      
      
8. Genomics with children 
   1. Explain specifically how either i., ii. or iii. is fulfilled: 
      1. It is about the child's clinical condition, the patient group gets a benefit, and you test data from research with competent or other experimental methods. Healthy children are discouraged from genomics 
      2. The experiment directly benefits the child, and genomics with adults does not provide the same benefit 
      3. Genomics can only be carried out with this age group, which benefits very much and is exposed to minimal risk. 
   2. Describe whether incidental findings may occur that do not become apparent until adulthood. 

When it comes to research on the deceased, a number of information included in the standard protocol will naturally have to be omitted, e.g. procedures for information and consent, etc. This guide has been supplemented with current legal rules to clarify the interface with the Danish Health Act. 

1. Describe whether it is research on material taken by autopsy (section 8(1) of the Committee Act): 
   
   1. Forensic autopsies (section 184 of the Health Act) 
      Specify whether: 
   2. The material was extracted before 1 January 2012 (no requirement for consent under the Danish Health Act), or 
   3. The material was extracted after 1 January 2012 (with consent pursuant to section 187 of the Danish Health Act, see the Ministry of Health's Guidelines on consent to research in tissues and other biological material taken by forensic autopsy. See Guidelines on consent for research on tissue and other biological material taken at a forensic autopsy. 
   4. Medical autopsies (with consent pursuant to section 187 of the Danish Health Act, see the Ministry of Health's Guidelines on consent to medical autopsies, etc. (hospital autopsies). 
      NB: Statements for information and consent do not need to be submitted. 
      
      
2. Describe that it is research on biological material from the deceased, but not an autopsy, cf. section 8(2) of the Committee Act: 
   
   1. The deceased's donation of the body to science pursuant to section 188 of the Health Act, or 
   2. Other interventions pursuant to section 8(2) of the Committee Act 
   3. That is, minor procedures such as blood draws, removal of skin areas and equivalent procedures (except removal of retinas that are treated as autopsies). 
      NB: Declarations for information and consent must be submitted. Find declarations of consent here. You can read more about research on the deceased in the committee system's Guidelines on research on the deceased