To update your trial information:. You are required to submit results of data. It is important to note that results-reporting requires a fairly sophisticated knowledge of the study. To report your trial results:. Under the FDA Modernization Act, NIH was instructed to establish a database of therapeutic clinical trials that is understandable and accessible to the public.
The purpose of this legislation was to make information about clinical trials available to members of the public who are suffering from diseases so they can apply to be research subjects. A clinical trial also clinical research is a research study in human volunteers to answer specific health questions.
Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.
The tutorials include a quick overview guide called Entering a New Registration that briefly summarizes how to use the tutorials to support registering a study. Patient registries may be single-purpose or ongoing data collection programs that address one or more questions. Observational study records should be updated and maintained in the same manner as interventional study records.
Expanded access records describe the procedure for obtaining an experimental drug or device outside of a clinical trial. Any manufacturer or Sponsor accepting requests for single-patient investigational new drug applications INDs or protocol exceptions including for emergency use should provide only one expanded access record.
Do not register each single-patient INDs or protocol exception separately. Expanded access records should generally be updated and maintained in the same manner as interventional study records. When registering a clinical trial that includes a drug that is also available via expanded access, the Availability of Expanded Access data element should be answered Yes see Expanded Access and Availability of Expanded Access on ClinicalTrials.
The bill would prohibit a plan contract or insurance policy from, among other things, discriminating against an enrollee or insured for participating in an approved clinical trial. The bill would authorize a plan or insurer to require a qualified enrollee or insured to participate in a clinical trial, as specified, and to restrict coverage to an approved clinical trial in this state, unless the clinical trial is not offered or available through a participating provider in this state. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state.
Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason. The people of the State of California do enact as follows:. Section A A qualified enrollee participating in an approved clinical trial conducted by a participating provider. A The study or investigation is approved or funded, which may include funding through in-kind donations, by one or more of the following:.
Subsequently, regulatory authorities around the world began to require the posting of clinical trial information and, in some cases, the submission of summary results to a publicly accessible registry. Likewise, some research funding agencies are now encouraging or requiring the registration and results reporting of the clinical trials they fund. The World Health Organization Trial Registration Data Set directs that the following 20 elements be included in a clinical trial registry [2]:.
The 24 clinical trial registries that are national, regional, or international in scope are listed below, along with relevant laws and guidance documents [3].
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