Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:
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1 Screening period/baseline (Day1)
Once it is confirmed that the subject meets the inclusion criteria and does not meet the exclusion criteria, the participation center will conduct randomization and research enrollment of the subject as soon as possible. The research steps are as follows:
Informed consent and sign the informed consent form;
Collect demographic data: gender, date of birth, nationality, height and weight;
? Collect the past medical history, allergy history, current concomitant diseases and treatment, the diagnosis name of this disease (traditional Chinese medicine diagnosis and western medicine diagnosis), and the treatment of this disease before enrollment;
? Physical examination;
? Sensory symptoms score (evaluated by researchers);
? Laboratory examination: blood routine test+CRP;
? Collect biological samples of subjects before administration;
? Vital sign examination, including temperature (measured within 15 minutes before the first administration), pulse, respiration, blood pressure, etc;
? Randomize at the last step before administration;
? 5 days of experimental drugs and 3 tablets of emergency drugs;
(If the subject completes randomization before 12:00, he/she can take the drug for three times on the same day, and stop taking the drug after three times on the fifth day. If the subject completes randomization within 12:00 to 18:00, he/she can take the drug for two times on the same day, and stop taking the drug after one time on the sixth day. If the subject completes randomization within 18:00 to 24:00, he/she can take the drug once after randomization, and stop taking the drug after two times on the sixth day.)
? Issue the thermometer, guide the subjects to use the thermometer and inform them of the daily measurement time, times and requirements;
? Instruct the subjects to fill in the temperature record form: the subjects began to measure and record from the measurement time point after enrollment.
? Instruct the subjects to fill in the symptom score, including the evaluation time, frequency and requirements, and the subjects start self-assessment and recording from the evaluation time point after enrollment.
2 Subject log card
From randomization to drug withdrawal (Day1-Day6/7), the subjects filled in the subject log card by themselves.
? Administration record form: the subjects record the administration of the test drug every day;
? Body temperature (armpit temperature) record form: the subjects' body temperature was measured at 8:00, 12:00, 16:00 and 20:00 every day, and the measurement time and results were recorded. When you feel that your symptoms are getting worse, your body temperature is rising, or you feel that your symptoms are decreasing, or your body temperature is dropping, you should measure your body temperature, and record the measurement time and results.
? Sensory symptoms score (self-evaluation by the subject): the subject self-evaluates the Sensory symptoms score table at 8:00 and 20:00 each day, recording the evaluation time and results.
3 Day 3
Telephone interview
? Shanggan Symptom Rating Scale (evaluated by researchers);
? Adverse events
4 The day of drug withdrawal or one day after drug withdrawal (Day 6/7)
Outpatient visit
? Vital sign examination: including temperature, pulse, respiration, blood pressure, etc;
? Physical examination;
? Shanggan Symptom Rating Scale (evaluated by researchers);
? Biological sample collection;
? Recording adverse events;
? Record the combined medication;
? Recording concomitant treatment;
? Recovery of test drugs;
? Check the filling of the subject's diary card;
? Complete the research summary sheet records.
5 Sampling and Processing
For all subjects, one tube of throat swab sample was collected during the baseline period (Day1). For subjects with sputum: collect 1 tube of sputum sample. Among them, 200 subjects collected a blood sample before administration, and collected a blood and throat swab sample (the same as the baseline requirements) on the day of the end of administration or 1 day after the end of administration (Day6/7) for multi pathogen detection and multi group detection.
Blood sample collection: after collecting EDTA anticoagulant blood collection tube (purple cap), gently reverse and mix for 5-8 times; Keep it at room temperature (18-25 ℃) for no more than 4 hours and at 4 ℃ for no more than 8 hours. Take the supernatant after centrifugation and freeze it at - 80 ℃. For 100 patients, collect the cell components in the sediment to separate PBMC for cryopreservation.
After collection of PAXgene RNA blood collection vessels, gently invert and mix for 8-10 times, and place vertically at room temperature (18-25 ℃) for at least 2 hours to ensure complete lysis of blood cells, and place at room temperature for no more than 8 hours. The PAXgene RNA collection vessel was then stored at - 20 ℃ or - 80 ℃.
The blood samples collected by the China Japan Friendship Hospital in the outpatient department were promptly transported to the microbiological laboratory for centrifugation, subpackaging and freezing. The blood samples collected by the research sub center shall be centrifuged, repackaged and frozen in the center in time, and then transported to the microbiological laboratory of China Japan Friendship Hospital in a unified cold chain for testing. Anticoagulant blood collection tubes and sputum sample collection tubes are provided by the research center, while RNA blood collection tubes, cryopreservation tubes, cryopreservation boxes, straws and throat swab sampling tubes are provided by the project team. The actual date and time of sample collection must be recorded in eCRF or sample processing record form. Instructions for the collection, handling, storage and transportation of samples are provided in the laboratory manual provided in this study. The collection, processing, storage and transportation of samples shall be carried out under specific and controlled (if conditions permit) temperature conditions as described in the laboratory manual.
The collection time, type, quantity, testing items and storage conditions of samples for scientific research are as follows:
Test time number of people sample type sample processing sub packaging test items total number of people saving
Day 1
(Before medication)
DAY 6
(Last visit) 200 people Whole Blood
5-10ml plasma 1ml*2tubus Proteome, Cytokine twice * 200 people -80℃
PBMC
(100 of them) Install in 3 tubes Single cell sequencing (partial) twice * 100 people liquid nitrogen
Deep sputum -- 1ml * 3 tubes Microbiome twice * 200 people -20℃/-80℃
Pharyngeal swab -- 1ml * 3 tubes 22 kinds of multi pathogen detection twice * 200 people -80℃
Whole blood (5ml) peripheral blood RNA PAXgene Blood RNA Tubes * 2 tubes transcription group twice * 200 people -80℃
Research Flow Chart
Baseline period/Day1 Day2 Day3 Day4 Day5 Day6/7
Inclusion and exclusion criteria
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Demographic data1 ●
Disease diagnosis and treatment before enrollment
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Other diseases, medication and treatment ● ●
Treatment of this disease before enrollment ●
Physical examination2 ● ●
Symptom score of upper sense ● ● ●
Biological sample collection
● ●
Laboratory Inspection3 ●
Vital signs ● ●
Drug distribution ●
Administration record form (subject self-evaluation) ● ● ● ● ● ●
Body temperature (axillary temperature) and emergency medication record form (self assessment by the subject) ● ● ● ● ● ●
Rating scale price of upper sensation symptoms (self assessment by the subject) ● ● ● ● ● ●
Rating scale of upper sensory symptoms (other comments by researchers) ● ● ●
Recycled drugs5 ●
Adverse event record ● ●
Conclusion ●
remarks:
1. Demographic data: sex, height, weight, date of birth, nationality;
2. Vital signs: including temperature, pulse, respiration and blood pressure;
3. Laboratory examination: blood routine examination (WBC, RBC, HGB, PLT, NEUT, LYM)+CRP, and screening and enrollment records once;
4. Pregnancy examination: women of childbearing age shall be tested for urine pregnancy at screening/baseline;
The treatment period of this study is 5 days. If the subject has been in the afternoon or evening when he was enrolled, he still needs to continue taking medicine on the sixth day, so it may be difficult for him to come to the hospital on the day of drug withdrawal on Day6. The patient can return to the hospital on the day of drug withdrawal or one day after drug withdrawal (Day7). In addition, during the trial, the temperature of the subject returned to normal, and other symptoms disappeared. After 24 hours, the investigator assessed that the subject did not need to take the test drug again, and he could return to the hospital on the day of drug withdrawal or one day after drug withdrawal.
data management
1 Data center
The clinical research institute of Peking University undertakes the project data management.
2 CRF design and electronic database construction
The clinical research institute of Peking University uses the CRF final version as the basis, and the database manager uses RedCap software to build the data collection system.
3 Data Management Plan and Data Verification Plan
The Clinical Research Institute of Peking University was responsible for drafting the Data Management Plan and the Data Verification Plan.
The data management plan refers to the detailed description of data management work, time plan and division of responsibilities of all parties in the whole process of the project. The clinical research institute of Peking University, researchers and the supervisor will sign the final draft after the research plan is finalized and before the project starts.
The data verification plan is a detailed description document of the project data verification, which is drafted by the Clinical Research Institute of Peking University after the research scheme and CRF are finalized, and reviewed and approved by the researchers. The data verification plan is a document that determines the data verification points and methods one by one according to the requirements of the research scheme and the specific content of CRF.
Based on the data verification plan, the data acquisition system is constructed for data verification.
4 Data Entry and Data Verification
The data entry personnel log in the electronic data collection system through their personal accounts to enter and modify data, and reply to data queries. The electronic data collection system will set up electronic verification procedures, including data logic verification, scheme deviation verification, outlier verification, etc. The system will automatically check and issue data queries online. In addition, the supervisor will issue data questions after checking the original documents on site, and the data entry personnel will answer data questions until all questions are solved.
5 Locking database and data audit
After all the data of the research objects have been entered, with the cooperation of the researchers, all the remaining data questions will be cleared and the research data will be frozen within 4 weeks. The researchers will no longer be allowed to modify the data to ensure the stability of the research data.
The frozen database was drafted by Peking University Clinical Research Institute and submitted to the data review meeting. With the presence of researchers, statisticians and Peking University Clinical Research Institute, possible data problems in the report were solved and statistical population was divided.
If the researcher confirms that there is no data problem in the frozen database, and the database is locked after the statistical population division is determined.
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