How to write a qualified chemical drug clinical study (trial) report?

The purpose of this guideline is to provide applicants for drug registration (applicants) or/and clinical investigators with reasonable ideas, so that they can organize a complete, clear, well-structured and easy-to-evaluate clinical trial report. The clinical trial report should provide a clear and complete description of the overall design of the trial and its key points; it should describe the trial implementation process in an organized manner; and it should include the necessary basic data and analytical methods so that the analysis of data and results can be reproduced. This guideline covers the following types of clinical studies: Phase I (tolerability and clinical pharmacokinetics), Phase II/III, and bioavailability/bioequivalence. For the technical requirements of these types of clinical studies, please refer to the relevant guidelines. This guideline mainly focuses on the format and content of the trial report, but also applies to other clinical studies for registration purposes. This guideline only provides a framework for the structure and content of the clinical trial report, and lists the basic points to be covered in the report, and it is not possible to be completely detailed. In view of the complexity of clinical research, the format and content can be adjusted appropriately according to the specific conditions of the study. Second, the structure and content of the clinical trial report (a) the first chapter The first chapter is the first part of each clinical trial report, all individual clinical trial report should contain the content of this part. The contents under each heading in the first part should be listed on separate pages. The first part of the content does not need to be labeled with the words "first". 1, the cover page title, including the generic name of the subject drug, the type of study, the study number, the date of commencement of the study, the date of completion of the study, the principal investigator (signature), the research unit (seal), the signature of the person in charge of statistics and unit seal, the applicant for registration of the drug (seal), the contact person and contact details of the applicant, the date of the report, the date of the study, the date of the report, the date of the report, the date of the report, the date of the report, the date of the report. Contact person and contact information of the registered applicant, date of the report, and the place where the original data are kept.2. Table of Contents List the contents of the entire clinical trial report and the corresponding page numbers.3. Summary of the study (with sample table) The summary of the completed study should be presented in terms of the results of the study in terms of the important data rather than in terms of the text and the P-value alone. If necessary, a list of completed clinical trials should be attached. 4. Ethics-related information It must be declared that the completed clinical trial is in strict compliance with the Declaration of Helsinki regarding the ethics of medical research on human subjects, and it must be declared that the protocol of the clinical trial and the application for its revision have been examined and approved by the Ethics Committee (IEC or IRB), and a copy of the approval of the Ethics Committee must be provided. Information on the study and a sample of the informed consent form must be provided. 5. Trial investigators List the names of the principal investigators of the clinical trial, their affiliations, responsibilities in the study, and their curriculum vitae (listed in the Appendix), including the principal investigator and the main participants in each center, the person in charge of the statistical analyses, and the person who writes the report of the clinical trial. 6. Acronyms List the full names of the acronyms used in the report of the clinical trial. (ii) Content of the main text and report format 1. Basic content This part is the principle description of the main items included in the format of various types of clinical trial reports. 1.1 Introduction Introduction to the background, rationale and justification for the development of the test drug, target indications, current treatment methods and therapeutic effects, etc.; description of the legal basis for the implementation of the study and the cooperation between the applicant and the clinical research unit. 1.2 Purpose of the trial Purpose of the clinical trial. 1.3 Trial management Describe the management structure of the trial and the implementation of GCP. The management structure includes the principal investigator, principal participants, steering committee, management/supervision/evaluation personnel, clinical trial organization, statistical analysts, central laboratory facilities, contract research organization (C.R.O.), and distribution management. The implementation of GCP refers to the training of trial participants, monitoring/auditing, reporting system of serious adverse events, laboratory quality control, statistics/data management, as well as problems occurring in the study and their handling measures, etc. 1.4 Trial design 1.4.1 Overall trial design and protocol description The overall design (e.g., parallel design, crossover design, etc.) and the description of the protocol should be clear and concise, and where necessary, the protocol should be described in a clear and concise manner. The overall design of the trial (e.g., parallel design, crossover design, etc.) and the description of the protocol should be clear, concise, and if necessary, use graphs and charts and other intuitive methods. This should include the following: treatment (drug, dose and specific use), subject population and sample size, method and degree of blinding (non-blind, single-blind, double-blind, etc.), type of control, study design (parallel, crossover), method of grouping (randomized, stratified, etc.), sequence and duration of the trial's phases (including the pre-randomization and post-treatment periods, the withdrawal period, and the single-blind and double-blind periods of therapy, and the timing of the randomization of the patients), and, wherever possible, the use of the "randomization" method. (including pre-randomization and post-treatment, withdrawal period and single-blind and double-blind treatment period, should specify the time of randomization of patients, and try to use flow charts to visualize the time schedule), data audit, and the plan to deal with safety issues or special circumstances, and interim analysis. 1.4.2 Consideration of experimental design and selection of control group The basis for the determination of the control group should be clarified and the reasonableness of the control group should be clarified. The rationality of the washout period and dosing interval of the drugs involved in the trial design should be explained. If randomization is not used, other technical measures to effectively overcome systematic selectivity bias should be explained in detail. If there is no control group in the study, the reason should be explained. 1.4.3 Selection of study subjects: Establish reasonable and feasible inclusion, exclusion, and delimitation criteria. Determine the inclusion criteria according to the purpose of the study, state the scope of indications and the basis for determining them, choose the recognized diagnostic criteria, pay attention to the severity and duration of the disease, the characteristics of the medical history, the scores of the physical examination, the results of the laboratory tests, the previous treatment, the factors that may affect the prognosis, the age, the gender, the weight, the race, etc. If necessary, make a reasonable argument. Reasonable justification was made when necessary. Exclusion criteria based on safety and ease of trial management should be described, with attention to the impact of exclusion criteria on the generalizability of the study as a whole and on the evaluation of safety and efficacy. Pre-determined exclusion criteria should be considered from a treatment or evaluation perspective and justified. The follow-up measures and duration of follow-up for excluded subjects should also be described. 1.4.4 Trial Procedure Describe in detail the application of the test drug in the clinical trial and related matters. List the name, dosage form, specification, source, batch number (if more than one batch number is used, the batch number used for each subject should be registered), expiration date and storage conditions of the test drug, and the control drug in special cases should be described and evaluated. The usage and dosage of the test drug (including the dosage and the basis for determining the dosage, the route and mode of administration, and the timing of administration) should be described in detail. Describe in detail the method and operation of randomization, the method of generating random numbers, and provide a randomization table in an appendix (multi-center studies should be listed separately for each center). Describe how the blinding was performed (how the bottles were labeled, the blinding process, setting up of contingency letters, dual simulation techniques, etc.), the conditions for emergency blinding, how the continuation of the blinding was ensured during data audits or interim analyses, and the rationale for why it was not possible to blind or could not be blinded, and how the control of bias was performed. Describe the use, contraindication, and documentation of drugs other than the test drug, their regulations and procedures, and evaluate their impact on the observed results of the subject drug, and how to distinguish and characterize their effects on the observed indicators from those of the subject drug. Describe measures to ensure good compliance (e.g., drug counts, diary cards, determination of drug concentrations in blood/urine and other body fluid specimens, monitoring of medical events, etc.). 1.4.5 Efficacy and Safety Indicators Includes specific efficacy and safety indicators, laboratory test items, measurement schedules, test methods, responsible personnel, flow charts, precautions, definitions of indicators and their results (e.g., ECG, EEG, imaging, etc.). Includes specific validity and safety indicators, laboratory test schedule, test methods, responsible personnel, flow chart, precautions, definition of various indicators and their test results (e.g., electrocardiogram, electroencephalogram, imaging, laboratory tests, etc.). Describe the method of obtaining adverse event data, the judgment criteria for adverse events found in laboratory tests, and their treatment. If the indicators of efficacy or safety used are unconventional, non-standard and special indicators, their accuracy, reliability and relevance should be explained. The primary endpoints for determining efficacy should be clearly stated and the basis for determining them should be provided (e.g., publications, study guidelines, etc.). If a surrogate is used, the rationale should be provided. For the determination of drug concentrations, the time between sampling of biological samples and the time of administration of medication, and the possible effects of diet, coadministration of medication, smoking, alcohol and coffee consumption on the administration of medication and specimen collection should be described in detail. Sample handling and measurement methods should be methodologically validated, and special cases should be described. 1.4.6 Data quality assurance A brief description of the quality control process to ensure that the data measured by the indicator are accurate and reliable, including the status of monitoring/auditing, consistency of data entry, range and logic checks, blind audits, and blinding processes. If necessary, relevant documents for quality control should be provided, such as the original records of data consistency checking, numerical range and logic checking, the original records of blinded auditing, and the questionnaire for the communication between the investigator and the monitor, etc. 1.4.7 Statistical treatment plan and sample size determination The definition of statistical analysis sets (full analysis set FAS according to the principle of intentional analysis, the compliance set PPS, the safety data set), the definition of test comparisons, the definition of the test comparison set, and the definition of the test comparison set (the test comparison set PPS, the test comparison set PPS, and the test comparison set PPS, etc.) should be listed explicitly. The definition of statistical analysis sets (FAS, PPS, safety data set), types of test comparisons (e.g., superiority, equivalence, or non-inferiority tests), definitions of primary and secondary indicators, statistical analysis methods for various indicators (recognized methods and software both domestically and internationally), and methods for evaluating therapeutic efficacy and safety should be clearly set out. Emphasis should be placed on how to analyze, compare and statistically test, and handle outliers and missing values, including descriptive analysis, parameter estimation (point estimation, interval estimation), hypothesis testing, and analysis of covariates (including the treatment of between-center effects in multicenter studies). The hypothesis to be tested and the treatment effect to be estimated, the method of statistical analysis, and the statistical model involved should be described. The estimation of treatment effects should be accompanied by confidence intervals and a description of the estimation method. Hypothesis tests should specify whether they are one-sided or two-sided and, if one-sided, the reason. Primary and secondary indicators should be clearly defined, and the exclusion of some cases with data from the analysis should be explained and elaborated upon. Any modifications to the statistical scheme of the study should be explained. Provide the specific method of calculating the sample size, the procedure for calculating it, and the estimate of the statistic used in the calculation and the source of the estimate.1.4.8 Modifications to the protocol during the trial The protocol should not be changed. Any modification of the ongoing study (e.g. change of treatment group, change of enrollment criteria, change of dosage, change of sample size, etc.) should be described and approved by the Ethics Committee. The time, reason, process of change and whether the change is documented or not should be explained in detail and the impact on the overall evaluation of the study results should be demonstrated. 1.4.9 Interim analysis Indicate whether an interim analysis was performed. If an interim analysis is performed, it should be performed according to the protocol and the method of calculating the alpha depletion function should be described. 1.5 Results 1.5.1 Study subjects 1.5.1.1 Description of subjects The number of subjects participating in the trial can be described graphically, including the number of screened subjects, the number of randomized subjects, the number of completed subjects, and the number of uncompleted subjects. All subjects who did not complete the trial should be analyzed by center and trial group with randomization code, demographic information (e.g., age, sex), time of enrollment and last visit, medication dose, concomitant use of other medications, reasons for not completing the trial (e.g., lost to follow-up, adverse events, poor compliance, etc.), and whether or not to continue to follow up with the subject and whether or not to break the blinding at the time of discontinuation of the medication. 1.5.1.2 Deviations from the trial protocol All deviations from the enrollment criteria, exclusion criteria, subject management, subject assessment, and study procedures should be described. The following categories should be listed and summarized in the report by center:?7?5 Subjects who did not meet the inclusion criteria but were entered into the trial?7?5 Subjects who met the exclusion criteria but were not excluded?7?5 Subjects who received the incorrect regimen or dose of therapy?7?5 Subjects who were concurrently taking other prohibited medications.1.5.2 Effectiveness Evaluation 1.5.2.1 Efficacy/Effects Analysis Dataset The data set of subjects participating in an effects analysis should be available to all subjects. Subjects participating in an effects analysis should be clearly defined, e.g., all subjects who have used the test drug or all subjects who have completed the trial according to the trial protocol, or all subjects who are in compliance with a particular regimen. Generally, the full set of analyses should be used for analysis. Subjects who used the test drug but were not included in the effects analysis data set should be described in detail. 1.5.2.2 Demographic and other baseline data Comparability analyses between trial groups should be performed using key demographic indicators and baseline characteristics. Comparability analyses at baseline should generally be performed using full analysis set analysis and, if necessary, protocol-compliant set analysis. Analyses should include demographic indicators such as age, gender, and ethnicity, as well as condition, duration of illness, factors influencing efficacy/efficacy analyses, and baseline values for key efficacy indicators for the indication.1.5.2.3 Adherence Adherence to the trial protocol by each subject during the trial should be measured and analyzed. Describe the methods and indicators used to ensure and record adherence, such as the number of follow-up visits, medication counts, diary cards, and various monitoring indicators. Measurement of drug concentration in blood/urine and other body fluid specimens should be performed when necessary. 1.5.2.4 Combination of medication Groups should be listed for all subjects during the trial period. 1.5.2.5 Analysis of efficacy/effectiveness All efficacy/effectiveness indicators should be clearly defined. Differences between treatment groups should be compared in terms of primary and secondary efficacy indicators and pharmacodynamic/pharmacokinetic parameters. The full analysis set and protocol-compliant set analyses should be performed according to the protocol.1.5.2.6 Efficacy Summary A brief summary of the efficacy and clinical significance of the subject drug should be provided through the analysis of the primary and secondary efficacy indices. 1.5.3 Safety Evaluation Any subject who has used the subject drug at least once should be included in the safety analysis set. This includes three levels: first, the degree of drug use/exposure, referring to the dose of the test drug, the duration of use, and the number of subjects who used the drug. Secondly, common adverse events and changes in laboratory parameters should be categorized in a rational manner, and appropriate statistical analyses should be performed to compare differences between groups and to analyze possible factors (e.g., time-dependence, dose or concentration, demographic characteristics, etc.) affecting the frequency of adverse reactions/events. Third, serious adverse events and other significant adverse events (those requiring clinical management such as discontinuation, dose reduction, and other therapeutic interventions). They are usually identified by analyzing subjects who withdrew from the study because of an adverse event. All adverse events should have a clear causal relationship to the drug. Adverse events are summarized graphically and those of major concern are described in detail. Adverse events should be reported for both the subject and control drugs. 1.5.3.1 Extent of drug use/exposure Duration of drug use/exposure is expressed as the mean or median duration of drug use, which may be expressed as the number of subjects at a given time, with subgroups by age, sex, disease, etc. The dose of drug use/exposure is expressed as the median duration of drug use. The medication/exposure dose is expressed as the median or mean, which can be expressed as the number of subjects at the average daily dose. Dose/exposure and duration of dose/exposure may be combined, e.g., how many subjects in a dose group were dosed/exposed for at least one month, and the number of subgroups should be listed by age, sex, disease, etc. Where possible, the concentration of the drug at the time of the adverse event or abnormal laboratory test should also be provided. 1.5.3.2 Adverse Event Analysis All adverse events for both the subject and control drugs should be analyzed and visualized in a graphical presentation that shows the frequency, severity, and causal relationship to drug use according to the system of accrual of the adverse event. The analysis should compare the incidence of adverse events in the subject and control groups, preferably categorized by severity and causality. Correlations with dose, duration of administration, baseline characteristics, and demographics should be analyzed as needed. Each Serious Adverse Event and Significant Adverse Event deemed necessary by the Principal Investigator to be reported should be summarized and analyzed in a separate section and accompanied by a case report. The case reports of subjects with serious adverse events and important adverse events should be provided in the appendix, including case number, demographic characteristics, the occurrence of adverse events (time of occurrence, severity, duration, treatment, outcome) and causality judgment. 1.5.3.3 Safety-related laboratory tests, vital signs, and physical examination Each laboratory test value, vital sign, and physical examination indicator should be described, as well as each indicator at each time point during the trial (e.g., at each visit). Provide appropriate analytical statistics, including the number of subjects with abnormal laboratory tests or abnormal values of a certain magnitude. Based on professional judgment, in addition to excluding abnormalities that are not clinically relevant to safety, clinically significant laboratory test abnormalities should be analyzed on a case-by-case basis, and the clinical significance of the alteration and the relationship to the subject's medication (e.g., relationship to dose, concentration, and co-administration of medications, etc.) should be discussed. 1.5.3.4 Safety Summary A summary of the overall safety of the subject drug, with emphasis on adverse events that resulted in dose adjustments, the need for additional therapy, discontinuation of the drug, or death. The potential significance of the adverse events for the broader clinical application of the subject drug is described. 1.5.4 Discussion and Conclusions Summarize the efficacy and safety results of the clinical study and discuss and weigh the benefits and risks of the subject drug. Do not simply repeat the results and do not introduce new results. The conclusions should be clear and unambiguous, and their significance and possible problems should be reviewed in the context of the literature to clarify the benefits and caveats of individual patient or population-based treatment and the implications for further research. 1.5.5 Statistical analysis report The statistical analysis report is listed in the Appendix, and the content of the report should include the following parts: 1) a brief description of the process of collecting and organizing the information in the entire trial. 2) a summary of the results of the trial. 3) a summary of the results of the trial. 4) a summary of the results of the trial, including a brief description of the results of the trial. 5) a summary of the results of the trial. 1) A brief description of the process of data collection and organization in the whole clinical trial. Including: the purpose of the clinical trial and study design, randomization, blinding and blinding audit process, the definition of primary and secondary indicators, the provisions of the statistical analysis set, as well as in the process of data collation of missing values and outliers, etc. 2) a precise and complete description of the statistical model. Including the choice of statistical analysis software (specify the full name and version of the statistical software), the content of the statistical description, the provisions of the test level, as well as hypothesis testing and the establishment of confidence intervals in the choice of statistical methods and their rationale. In case of data transformation during statistical analysis, the reasons and justifications for data transformation should also be provided.3) Description of baseline characteristics and statistical test results of each group of cases at the time of enrollment.4) Analysis of efficacy/effects, including statistical descriptions of various types of observational indexes (primary indexes, secondary indexes, etc.) and results of hypothesis tests for each group of cases. The results of the statistical descriptions should be given for each observation time point. List the test statistics and p-value of the hypothesis test. For example, the results of the t-test for two samples should include the number of cases in each sample, the mean and standard deviation, the minimum and maximum values, the t-value and P-value for the comparison of the two samples; when analyzing the validity of the primary indicators by ANOVA, the analysis of variance should be performed by taking into account the effects of the baseline values of the treatment, center, and the indicators of the analysis; for the analysis of the data of the crossover design, the data of the order of treatment, and the number of patients in the order of treatment should be included, For the analysis of crossover data, it should include information on treatment sequence, number of patients in the treatment sequence, baseline value at the beginning of each phase, elution period and length of elution period, shedding in each phase, and ANOVA table for analyzing the interaction of treatment, phase, and treatment and phase. 5) Safety evaluation of each group of cases, mainly based on the statistical description of the drug/exposure situation (duration of the drug, dosage, and concentration of the drug), the incidence rate of adverse events, and the specific descriptions of the adverse events; the changes of laboratory test results before and after the trial. Laboratory test results before and after the test changes; abnormal changes and their relationship with the test drug. 6) multi-center study, the content should include the enrollment of subjects in each center, the trial program deviation, demographic and other baseline data descriptive analysis, the main efficacy indicators and secondary efficacy indicators of the statistical description of the occurrence of adverse events and their treatment and descriptive analysis. The above results should be presented in statistical tables and graphs as much as possible. The conclusions of the statistical analysis should be presented in precise statistical terms. All statistical calculations should be documented for verification purposes.1.5.6 Center Summary of Multicenter Clinical Trials Each center in a multicenter study should provide a summary table (see sample table in the Appendix). The summary form for each center should be completed by the principal investigator of the center, and must be stamped by the unit and signed by the person who completes the form. The content should include the enrollment of subjects in the center, the management of the trial process, the occurrence of serious and important adverse events and their treatment, and the commitment of the principal investigator of the center to the authenticity of the clinical trial.1.6 References The relevant references of the study report should be listed in Vancouver style, and the copies of the main literature should be listed in the Annex. 2. Phase I clinical trial 2.1 Tolerability trial report format 1) the first 2) introduction 3) the purpose of the trial 4) the management of the trial 5) the overall design of the trial and the description of the program 6) the trial design considerations 7) the selection of subjects (inclusion criteria, age, gender, ethnicity, body weight, physical examination, exclusion criteria, the number of cases) 8) the subject of the drug (name, dosage form, source, batch number, specifications, expiration date, 9) Route of administration (including the basis for determining the route of administration) 10) Dose setting (initial dose, maximum test dose, dose grouping) and the basis for determining the dose 11) Test procedure/test steps 12) Observation indexes (symptoms and signs, laboratory tests, special tests) Observation table 13) Data quality assurance 14) Statistical processing program 15) Modifications during the test 16) Test results and analysis (subject's age, gender, ethnicity, weight, exclusion criteria, cases) 16) Test results and analysis (general condition of subjects and analysis, comparability analysis between dose groups, results of each observation, data processing and analysis, observation and analysis of adverse events) 17) Conclusion 18) Explanation of special circumstances of the test 19) Bibliography of main references 20) Annexes (1, 2, 3, 4, 5, 7, 9, 11, 12, 14) 2.2 Reporting format of clinical pharmacokinetic test 1) First paragraph Report format of clinical pharmacokinetic trial 1) First part 2) Introduction 3) Purpose of the trial 4) Trial management 5) Overall design of the trial and description of the protocol 6) Consideration of the trial design 7) Selection of subjects (inclusion criteria, age, gender, ethnicity, body weight, physical examination, laboratory tests, exclusion criteria, number of cases) 8) Drugs to be tested (name, dosage form, source, batch number, specifications, validity date, preservation condition) 9) Route of administration and basis for determining the dose 10) Dosage form (1, 2, 3, 4, 5, 7, 9, 11, 12, 14) Annexes (1, 2, 3, 5, 7, 11, 12, 14) and the basis for determining 10) Dose setting and the basis for determining 11) Biological sample collection (sample name, collection time, disposal method) and the test process 12) Biological samples for drug determination: a detailed description of the analytical method and the basis for the selection (instrumentation, analytical conditions, the use of controls, such as the drug under test, the metabolite, the purity of the internal standard) and the confirmatory evidence (the lowest limit of quantification, specificity, precision, accuracy, Extraction recoveries, standard curves, etc.) Sample stability studies and quality control data quality assurance of the assay 13) Statistical processing protocols 14) Modifications during the trial 15) Study results data (chromatograms of samples from 20% of subjects and accompanying quality control samples, measured data from various biological samples, data processing, statistical methods and results, pharmacokinetic parameters, drug-timing curves) 16) Results of the study (chromatograms of samples from 20% of subjects and accompanying QC samples, data processing, statistical methods and results, pharmacokinetics parameters, drug-timing curves) 16) Results of the study (results of the study). -16) Observation and analysis of adverse events (including laboratory results) 17) Analysis and evaluation of results (including observation of adverse reactions) 18) Conclusion 19) Description of special circumstances in the trial 20) Main references 21) Annexes (1, 2, 3, 4, 5, 7, 9, 10, 11, 12, 14) 3. Phase II/III clinical trial report Format of Reporting of Phase I/III Clinical Trials 1) Preface 2) Introduction 3) Purpose of the Trial 4) Trial Management 5) Trial Design and Trial Procedure ?7?5 Description of the Overall Trial Design and Protocols ?7?5 Considerations on the Trial Design and the Selection of the Control Groups ?7?5 Scope of the Indications and the Basis for Determining Them ?7?5 Selection of Subjects (Diagnostic Criteria and the Basis for Determining Them, Inclusion Criteria, Exclusion Criteria, and Exclusion Criteria, Sample size and the basis for determining the sample size) .7.5 Grouping method .7.5 Test drug (including the name of the test drug, control drug, dosage form, source, batch number, specification, expiration date, storage conditions) .7.5 Dosing plan and the basis for determining the drug (including the dose and the basis for determining the dosage, the route and mode of administration, and the time schedule for administration, etc.) .7.5 Trial steps (including the schedule of visits) .7.5 Observations and the duration of the observation (including primary and secondary efficacy indicators, safety indicators) ?7?5 Efficacy evaluation criteria ?7?5 Data quality assurance ?7?5 Statistical treatment protocol ?7?5 Modifications during the trial and midterm analysis 6) Results of the trial ?7?5 Description of the allocation, dropout and exclusion of subjects ?7?5 Deviations from the trial protocol ?7?5 Demographics of subjects, baseline situation and comparability analysis ?7.5 Compliance analyses ?7?5 Combination results and analyses, efficacy analyses (primary and secondary outcomes and analyses, efficacy ratings), and efficacy summaries ?7?5 Safety analyses (analysis of the extent of dosing, description and analysis of all adverse events, description and analysis of serious and important adverse events, and analysis of the results of safety-related laboratory investigations, vital signs, and physical exams), and safety summaries ?7?7 Discussion and conclusions regarding the trial ?7?8 The trial was conducted in accordance with the following criteria 8) Description of special circumstances of the trial 9) Summary of each center of the clinical unit 10) List of major references 11) Annexes (1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14) 4. Report format of bioavailability/bioequivalence trial 1) First paragraph 2) Introduction 3) Purpose of the trial 4) Trial management 5) Overall design of the trial and description of the protocol 6) Comment on the design of the trial and description of the protocol 6) Considerations on trial design and selection of reference drug 7) Selection of subjects (inclusion criteria, age, sex, weight, physical examination, laboratory tests, exclusion criteria, number of cases) 8) Test drug (including name, form, source, lot number, specification, expiration date, storage conditions of the test drug and reference drug) 9) Route of administration and basis for determining the dose 10) Dosage and basis for determining the dose 11) Collection of biological samples (name of the sample, collection of the sample and the basis for determining the dose) 11) Collection of biological samples (name of samples, time of collection, method of disposal) and test procedure 12) Pharmaceutical determination of biological samples ?7?5 Determination methods (instruments, reagents) and validation (lowest limit of quantification, specificity, precision, accuracy, recovery, standard curve, etc.) ?7?5 Examination of the stability of the samples ?7?5 Quality control of the determination methods 13) Quality assurance of the data 14) Modification and analysis of the test during the course of the trial 15) Data on study results Chromatograms of 20% of the samples and chromatograms of the accompanying QC samples ?7.5 Blood concentration-time curves (individual and average) ?7.5 Measured data, data processing, statistical methods and results ?7.5 Pharmacokinetic parameters 16) Evaluation of bioequivalence 17) Observations and analyses of adverse events (including laboratory tests) 18) Observations and analyses of the results of the trials concerned. 18) Description of special circumstances in the trial 19) Main references 21) Annexes (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14) (3) Annexes 1) Ethics Committee approval 2) Information on the study presented to the subjects and a sample of the informed consent form of the subjects 3) Information on the clinical research unit and its qualifications, names of the principal investigators, their qualifications, responsibilities in the study, and their units, Qualifications, responsibilities in the study and curriculum vitae of the principal investigators 4. Clinical trial protocol, modifications to the protocol and approval of the modifications by the Ethics Committee 5. Copies of chromatograms of 20% of the samples of the subjects, including the standard curves of the corresponding batches of the analyzed samples 6. Sample of the case report form (CRF) 7. Total randomization table 8. Test reports and trial records of the tested drugs (including the placebo) Instructions for the positive control drug, the trial drug, the test drug, the test drug, the test drug, the test drug, the test drug, the test drug, the test drug, the test drug, the test drug, the test drug, the test drug and the test drug. Instructions for the positive control drug, the instructions for the test drug (if the drug is already on the market) 9, if the test drug includes multiple lot numbers, the registration form of the lot number of the drug used by each subject 10, a copy of the chromatograms of the QC samples, the drug-time curve of the individual subjects 11, serious adverse events and the principal investigator believes that it is necessary to report the case report on the important adverse events 12, the report of statistical analysis 13, multi-center clinical trials of the center summary table 14, clinical research, a copy of the main references (d) Sample form 1, the study report cover title sample Name of the study: Study No.: Test drug generic name: applicant for registration of the drug: (seal) Study start date: Study completion date: the principal investigator: (Signature) the unit in charge of the study: (seal) the applicant's contact person: the date of the report: Contact information (telephone (e.g., e-mail, e-mail address). Contact information (telephone, e-mail, mailing address): 18 Where the original information is kept: 2. Sample abstract of study report Applicant for drug registration Name of the study drug Name of the study: Researchers: Bibliography of published papers (references) of the study: Time of the study: Starting time Ending time Objectives of the study: Study methodology: Number of subjects (planned and analyzed): Inclusion and exclusion criteria: Subjects Specification, lot number and dosage of drug: Specification, lot number and dosage of control drug: Evaluation criteria Efficacy indicators (primary and secondary): Safety indicators: Judgment criteria: Statistical methods: Results and conclusions Efficacy results: Safety results: Conclusion: Date of report: 193. Sample table of summaries of multicenter clinical trials for each center Sample table of summaries of multicenter clinical trials for each center Clinical trial title Clinical Trial Approval No. Approval Date Applicant for Drug Registration Name of Clinical Trial Organization and Specialty Name of Trial Manager of the Center Position/Title of Participant (Schedule available) Provide information such as name, title, department, and division of labor in the study Name of Ethics Committee Date of Approval by Ethics Committee Date of Enrollment of the First Subject Date of Enrollment of the Last Subject Date of Completion of Follow-up No. of Subjects Planned to be Enrolled in the Trial Screening Number of subjects enrolled Screening Number of subjects enrolled (randomized) Number of subjects completing the trial Number of subjects failing to complete the trial Summary of subject enrollment (a schedule is available) The number (or initials) of all subjects who signed the informed consent form, the date of informed consent, the reason for failure at screening, the date of enrollment, the drug number, and the reason for discontinuation of those who failed to complete the trial and the date should be provided. The source of primary data Describe the basis for the establishment of the primary indicators of clinical efficacy and safety. Description of the instrument, assay, laboratory and normal value range used to collect the data. Blinding status during the trial Blinding status of the trial: □ double-blind □ single-blind □ non-blind If the trial is double-blind, is there any emergency blinding? □No □Yes If yes, provide details of the emergency blinded subjects Serious and important adverse events Serious adverse events:□No □Yes Important adverse events:□No □Yes If yes, provide details of the subjects with serious and important adverse events and the relationship with the test drug. Clinical Trial Supervision Unit of Clinical Trial Supervisor:□Applicant □CRO Supervision: Quality Assessment of Supervision: Comment of Principal Investigator The principal investigator of the Center shall comment on the quality control of the clinical trial and the trial situation, and declare the authenticity of the trial results. Signature of the principal investigator of the center: Date: 20 The center's clinical trial organization management review comments seal: Date: Remarks: The title of the clinical trial should specify the phase and project of the clinical trial. Intention To Treat Principle: A treatment strategy that evaluates a patient based on the desire to treat him or her (i.e., a planned course of treatment) rather than on the actual treatment given. This principle holds that the effectiveness of a treatment program is best judged on the basis of the intention to treat the patient rather than the treatment actually given. The result is that patients randomized to each treatment group should be followed, evaluated, and analyzed as members of that group, regardless of their compliance with the planned treatment. Full Analysis Set: The ideal set of cases that is as close as possible to the intention-to-treat principle, obtained by excluding the fewest and unreasonable cases from all randomized subjects. Per Protocol Set: Also known as valid cases, valid samples, evaluable case samples. A dataset generated from a subset of cases that are sufficiently adherent to the trial protocol to ensure that the data will demonstrate therapeutic efficacy according to the scientific model on which it is based. Adherence includes considerations such as acceptance of the treatment, measurability of key indicators, and no major violations of the trial protocol. Safety analysis set: The set of subjects used for summarization in safety and tolerability evaluations is referred to as the safety analysis set.