Annex 12: Description of the phases of clinical trials of medicinal products The Danish legal contracts for clinical trials are a cooperation agreement between the pharmaceutical company and the German Medical Association. The contract is required in writing on paper, regardless of the person of both parties who concludes it. Danish legal contracts Translation services can be used if you wish to receive the contract in another language. The power of attorney authorizing representatives of foreign authorities to access litigants` health information should be clearly displayed as a power of attorney and be formulated accurately to avoid any doubt as to what it covers. The authorisation should therefore be a separate document dealing with access to and purpose of access to health information for participants. Get inspired Office for Clinical Trials Denmark works closely with the Danish Ministry of Foreign Affairs, the Danish Health and Medicines Authority, the Danish Ministry of Health and the Danish Pharmaceutical Industry Association. This means that we are on the same page and working towards the same goal, which makes the processes for conducting clinical trials more transparent. We have found that being a small country is by no means a disadvantage. It is important that a country like Denmark shows the world that clinical trial placement can be conducted efficiently and productively in the future.
Other Nordic countries could easily set up a similar body, and the Nordic countries together could have much greater potential. Many pharmaceutical industries are already establishing their local offices as representatives of the northern region, and we are often seen as a group of nations. Although we may be different when it comes to individuals, we are much more united. In addition, many of our clinicians already have academic collaboration across borders. For example, when it comes to rare diseases, a country may not have enough patients to be included in a study – but in a northern region as a whole, we may have the resources compared to other large countries. We are constantly competing globally, so the need to work across borders is greater than ever. It is important to ensure that the Nordic countries can be considered an ideal location for industry-sponsored clinical trials in the future. Since non-commercial sponsors are not expected to have access to the SUSAR database, reporting of this type of sponsor can be made by completing and submitting the Danish Medicines Agency`s electronic form to report non-commercial sponsors of suspected unexpected serious adverse reactions (SUSAR) in clinical trials. The Clinical Trials Facilitation Group (CTFG) conducted a detailed review of european regulatory authority recommendations regarding contraception and pregnancy testing in clinical trials.
We recommend that you keep abreast of the CTFG`s recommendations. In Denmark, you benefit from the registration of patients and the population. The Danish population is homogeneous with recorded and easily accessible data that provide unique information about the patient population. Denmark has established public health and death registers and a single system of social security numbers. Thus, data are available for studies, making Denmark particularly suitable for epidemiological and clinical research. The Danish population is fairly homogeneous and relatively unmobile, making it ideal for longitudinal studies as the loss rate is very low. Patients participating in a clinical trial should be provided with written and oral information about the study. Before starting the study, participants must give informed consent to participate. For more information, see the Guidelines for Clinical Trial Applications, Amendments and the End of Trials Declaration, ec.europa.eu/health/documents/eudralex/vol-10/index_en.htm, which is accompanied by examples of significant changes requiring approval from the Danish Medicines Agency before the changes can be implemented. Go to: eudract.ema.europa.eu/document.html and click on: “Clinical Trial Application Form”.
Following the implementation of the General Data Protection Regulation, clinical trials of medicinal products no longer need to be reported to the Danish Data Protection Authority. The application form can be found under eudract.ema.europa.eu/eudract-web/index.faces. Look at the “Create” button in the top bar and select Clinical Trial and EEE (if you want the trial to be conducted in the EU). One. Clear indication of the primary and secondary endpoints of the study. Both parties subject to the contract agree on all conditions. Individuals who are to assume responsibility for the investigational drug must be qualified for the position, that is, they must have appropriate training and experience. Sponsors and the establishment where the drug review is conducted verify trained staff.
Annex 1 of the BPC Regulation stipulates that a trial report must contain, inter alia, the following information: Annex 1: Extract from the Danish Medicines Act (No 1180), as amended on 12 December 2005, Annex 2: Executive Decree on Clinical Trials of Medicinal Products on Humans (No 295, as amended on 26 April 2004 and amendments to Executive Decree No 903 of 18 August 2006) Annex 3: Executive Decree on the Clinical Practice of God on Clinical Trials – Human, No. 744, Amendment of 29 June 2006. Annex 4: Implementing Regulations on fees for the application for authorisation of clinical trials Annex 5: Application form for authorisation of clinical trials in humans Annex 6: Notification of amendment Annex 7: Explanation of the end-of-trial formAnnex 8: List of guidelines Annex 9: Form for the notification of suspected unexpectedly serious adverse reactions in clinical trials (CIOMS). Annex 10 Checklist for applying for authorisation of a clinical trial Annex 11: Overview of adverse reaction reporting (Annex deleted) The authorisation requirement under the Danish Medicines Act covers all prospective trials in the clinical evaluation of medicinal products (phases I to IV, including pilot studies). c. Procedures for recording and reporting adverse events/adverse reactions (see section 12 on adverse events/effects), including the length of time such records should be maintained after the subject has stopped using the investigational medicinal product. In addition, how these individual reports should be discontinued/withdrawn after the end of the trial – final report – when and how subjects should stop/leave the drug under trial The Directive introduces the requirement that all phases of clinical trials of medicinal products in humans must be conducted in accordance with PCBs, an internationally recognised ethical and scientific quality standard. Thus, PCBs encompass both the ethical and scientific aspects associated with clinical trials. Adhering to GCP standards to protect the rights, safety and well-being of subjects helps ensure that it is ethical to allow people to participate in drug trials. At the same time, it is necessary that the study be planned, conducted and reported in accordance with pcBs in order to ensure scientifically acceptable implementation.
Study data should be well documented and accurate to ensure reliable study results that can be used as documentation for the approval of a drug and its use in the treatment of patients. Appendix 9: Suspected Adverse Reactions of Unexpected Severity in Clinical Trials (CIOMS) Reporting Form. What aspects of data protection should be taken into account when conducting clinical trials? Although the registry does not publish Phase 1 studies, the results of these studies must be submitted to the DMA within one year of completion. When processing applications for trials of gene therapy and somatic cell therapy medicinal products and medicinal products containing genetically modified organisms, the 60-day period shall be extended by 30 calendar days. For these medicines, the 90-day period may be extended by an additional 90 days in the event of consultation with public or similar bodies. The protocol indicates the adverse reactions and adverse events to be reported by the investigator to the sponsor and the time when the report should be made after the detection of the adverse reaction(s). f. References to literature and data that are relevant and form the basis of the study. Clinical studies with euphoric substances require special attention to the subject`s ability to drive a motor vehicle. .