Preliminary Work
A decision must be made whether or not to obtain a consent to use collected data for research studies from the included participant/patient. A well-designed consent letter will allow for a broad, useful and correct use of the collected data for the future. It is therefore very important to design as comprehensive a consent as possible in relation to the intended use of data in either the study or the registry. The main rule is that one should always obtain consent from a patient before including it in a study or in a registry. The exception is if you do quality assurance of your own medical practice; then it is not required to obtain a consent to use already collected health information. In cases involving patients who are very ill, dead or where it may otherwise be difficult to obtain a consent, the Regional Committees for Medical and Health Research Ethics (REK) may grant exemption from the consent requirement.
Good registry data accurately measures the data that forms the basis for reports or analyzes. It is common to use a clinical standard and a standardized unit of measurement that is validated. There may be several medical methods available to perform a test or clinical measurement. You will have to make some choices regarding which measurement methods are desirable to use, and how to accurately record these data in a registry. It is also very important that you measure the same parameters over time in a consistent and predictable way, so that the analyzes you conduct remain reliable.
It is of great value to be able to link data you have collected with other relevant registry data. Examples of this are data from the Cancer Registry, the Cause of Death Registry, and the Prescription Registry. The advantage of linking data from multiple registries is that you can increase the amount of data, and thus answer and elucidate more questions than you would otherwise be able to. In many cases, collecting data by yourself is also time consuming and demanding. Given that the information you are looking for exists elsewhere, you will avoid a significant extra workload collecting data. Some data are only available within national registries, such as the Cause of Death Registry. The possibility of linking data from multiple registries should routinely be described in a consent form if the purpose is research on registry data.
It is also important to consider whether data should be disclosed to other persons outside the registry, and especially if data should be disclosed abroad. Research studies are often multinational, and it may be necessary to send data across national borders. This must be taken into account in the consent form and in other documents, such as patient information letters and in the protocol. See also the section "Using Registry Data".
Planning and producing a research or registry protocol is required. Long-term research registries (with broad consents) also require a steering committee. Such a committee typically consists of a mix of clinicians with a medical background in addition to one or several registry owners/administrators. For registries that are organized across several Health Regions (HR) and hospitals, there will typically be a representative from each HR who is a member of the group. The group makes important choices regarding the use of data and the future development/administration of the registry.
Planning and producing a research or registry protocol is required. Long-term research registries (with broad consents) also require a steering committee. Such a committee typically consists of a mix of clinicians with a medical background in addition to one or several registry owners/administrators. For registries that are organized across several Health Regions (HR) and hospitals, there will typically be a representative from each HR who is a member of the group. The group makes important choices regarding the use of data and the future development/administration of the registry.
It is a good idea to produce procedures (SOPs) that deal with the daily operation of the registry and the provision of data deliveries. A registry protocol/procedure provides clear instructions on how a registry should be managed and operated on a daily basis. It outlines who is responsible for the registry, what IT systems to use, detailed inclusion criteria and/or exclusion criteria, and which disease areas are relevant. The purpose of the registry should be clearly stated in the protocol. It will also detail requirements for disclosure and use of data collected. Such a protocol creates clarity and division of responsibilities in the registry. For examples of registry protocol template, see "Agreements and Templates".
Running a long-term research or quality registry can be very resource intensive, and one should have considered how much extra resources this entails at start-up. The basic rule for calculating resource use on a daily basis is based on how much time is consumed in order to collect all relevant clincial data for a patient. The time used is then multiplied by the number of patients per year included in the registry. On top of this one has to calculate in considerable time for data quality checks and data management. This provides a good indicator of how many hours a registry must dedicate annually in order to manage daily business. Larger registries depend on having dedicated permanent resources available.
It is also important to ensure that those who work with the registry on a daily basis have sufficient technical and statistical expertise and understanding of registry operation. Such a key competence is, for example, quality assurance of data collected in the registry. This is a continuous work, and is of great importance for the validity of the registry and its potential for later use. It is important to use sufficient resources to ensure that data collected is to be trusted, and that the number of responses is as high as possible, so that the coverage rate is high.
It is also important to ensure that those who work with the registry on a daily basis have sufficient technical and statistical expertise and understanding of registry operation. Such a key competence is, for example, quality assurance of data collected in the registry. This is a continuous work, and is of great importance for the validity of the registry and its potential for later use. It is important to use sufficient resources to ensure that data collected is to be trusted, and that the number of responses is as high as possible, so that the coverage rate is high.