Description

1. Research contents:

In the Chinese Headache and Vertigo Registration Study, patients aged 4-99 years with headache (primary headache and secondary headache such as migraine and tension type headache), vertigo (vertigo diseases such as vestibular migraine) and chronic pain (fibromyalgia and other diseases) were collected. The biomarkers, imaging features, right-to-left shunt of the heart (lung), genetic characteristics, treatment, and outcome (in relation to other diseases) of headache-related diseases were studied, and long-term follow-up was planned.

2. Research target:

We study biomarkers, imaging features, right-to-left shunt of heart (lung), genetic features, real-world treatment studies, and outcomes (in relation to other diseases) for headache and vertigo related diseases.

3. In order to ensure the quality of the trial, the sponsor and the researcher shall discuss and formulate the clinical research plan before the trial officially begins. GCP training was given to the relevant researchers who participated in the experiment. The research center must manage experimental drugs in accordance with (SOP), including receipt, storage, distribution and recycling. In accordance with the GCP guidelines, necessary steps should be taken during the design and implementation phase of the study to ensure that the data collected are accurate, consistent, complete and credible. All observed results and abnormal findings in clinical trials should be verified and recorded in time to ensure the reliability of the data. The instruments, equipment, reagents and standards used in various examination items in clinical trials should have strict quality standards and ensure that they work under normal conditions. The researcher inputs the information required by the program into the eCRF, and the inspector verifies whether the filling is complete and accurate, and instructs the staff of the research center to make necessary corrections and supplements. The drug regulatory department, the institutional review committee (IRB)

/ independent ethics committee (IEC), sponsor inspectors and / or inspectors may conduct systematic inspections of clinical trial-related activities and documents to evaluate whether trials are conducted in accordance with the requirements of the study program, SOP and relevant regulations (e.g. GCP, GMP), and whether trial data are recorded in a timely, true, accurate and complete manner. The inspection should be carried out by personnel who are not directly involved in the clinical trial. In order to meet the audit and / or inspection requirements of the regulator

, the researcher / institution must agree to keep the relevant records, including the identification numbers of all subjects (sufficient information is linked to the records, such as eCRF and hospital records), all originally signed informed consent forms. All eCRF copies, safety report forms, original records, treatment details, related communication documents (such as letters, meeting minutes, phone reports). Researchers / institutions are required to keep records in accordance with relevant specifications.

Relevant Chinese regulations and research institutions' requirements for the protection of subjects' personal information. Authorized representatives and regulatory agencies to examine (and copy if permitted by law) clinical records for quality review, inspection, and evaluation of safety, research progress and data validity. Raw data is all the information necessary to reconstruct and evaluate clinical research and is the original record of clinical findings, observations or other activities. Examples of these original documents and data records include, but are not limited to: hospital records, laboratory records, memos, subject diary cards, pharmacy dispensing records, audio recordings of consultation meetings, automated instrument records, verified as accurate and complete copies or transcripts, microfilm, photographic negatives, microfilms or disks, x-rays and stored in pharmacies participating in the study, documents and records of subjects in laboratories and medical technology departments.

4. Statistical analysis plan Differences between the two groups will be tested using the Mann-Whitney U test. P <0.05 indicates a significant difference. SPSS will be used. All statistical analyses will be based on the intent-to-treat principle using the full analysis set.