clinical study report of patient illness

A medical case study report is a published document in which doctors document and share their experiences treating patients so that other doctors can learn from them. They are written according to a specific format. This keeps them logical and helps readers quickly find the information they are looking for.

Full Answer

How to write a clinical study report?

The clinical study report should include an explanation of the critical design features, the plan, methods and conduct of the study, individual patient data and details of analytical methods.

What is the signature for a clinical study report?

Clinical Study Report [Study Title] [Study number] [Dd month yyyy] CONFIDENTIAL Signature pages for clinical study report I have read this report and confirm that to the best of my knowledge it accurately describes the conduct and results of the study.

What is the difference between a clinical study report and CSR?

The content of CSRs is detailed in the ICH guideline E3. A clinical study report provides a clinical and statistical description, presentations and analyses of the completed study.

How to write a CSR introduction for a clinical trial?

When available, utilize any state-of-the-art analysis of the product/therapy from the protocol for your CSR introduction. If not available, you can briefly summarize the study design, objectives, and population and then you’ll need to craft a novel but brief state-of-the-art analysis based on literature review.

What is included in the clinical study report?

CSRs also include extensive details on the course of treatment for patients, the medical information collected from the patients as part of the research, and demographic data, as well as other kinds of information to explain how the trial was conducted and results were analyzed.

How do you write a clinical trial report?

A Guide to the Clinical Study ReportA synopsis that provides a summary of the content in the CSR.A methodology section, which introduces the study compound and the methods for conducting the study.The results and conclusions sections, which present the data from the study and a summary of conclusions about the data.More items...•

What is an example of a clinical study?

For example, researchers may collect data through medical exams, tests, or questionnaires about a group of older adults over time to learn more about the effects of different lifestyles on cognitive health. These studies may help identify new possibilities for clinical trials.

Which guideline is used in clinical study report?

This International Conference on Harmonization (ICH) document makes recommendations on information that should be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects.

How do you summarize a clinical study?

5 Guidelines for Writing Clinical Trial Lay SummariesUse short sentences. The number one thing you can do to make your lay summary easier to read and translate is to shorten your sentences. ... Standardize terminology. ... Use consistent grammar and style. ... Avoid jargon and scientific/medical language.

How do you write a clinical summary?

4 tips for writing clinical paper summariesKnow how the clinical paper summary will be used. ... Read the article properly. ... Don't forget tables and figures. ... Explain the clinical finding in your own words.

What is clinical studies in medical?

Listen to pronunciation. (KLIH-nih-kul STUH-dee) A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease.

What are the 3 types of clinical trials?

Types of clinical trialsInterventional trials aim to find out more about a particular intervention, or treatment. ... Observational studies aim to find out what happens to people in different situations. ... Feasibility studies are designed to see if it is possible to do the main study.More items...•

How do I start clinical research?

Compile IRB Submission. An Institutional Review Board (IRB) submission is required for any human subject research study. ... Determine if a study needs a Data and Safety Monitoring Board. ... Follow Up on Status of Contract and Budget Approval. ... Recruitment Enhancement Core (REC)

When is a clinical study report required?

This report is required if the study is to be used to support approval by a regulatory agency, such as the FDA or European Medicines Agency (EMA), or that support the information in the product label.

What are the 3 main GCP principles?

Subject's Rights, Safety, and Bell-Being. ICH GCP Principle 3 states that the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

When should a clinical study report be submitted?

IND application must submit annually (i.e., within 60 days of the anniversary of the date that the IND was initially accepted by the FDA) an Annual Report to the IND application/FDA. The Annual Report must include a written summary of the status of all clinical studies being conducted under the IND application.

What is a CSR report?

The report is a comprehensive look at all the data produced in a clinical study, presented in text, tables, and figure formats. It will often include discussions and conclusions that provide context to the findings regarding the drug, device, biological product, surgical method, counseling practice, or any other type of therapeutic product or practice under study and where it may contribute to an improvement on the state of the art for treating or preventing a particular health condition.

Why is cross functional review important?

The purpose of a cross functional review of a CSR is to confirm accurate key study messaging and data ; allow medical review of the patient narratives, outcomes, and conclusionary statements; review the logical flow of ideas; and ensure that the CSR language is consistent across any other study document (i.e., the protocol, statistical analysis plan, etc.).

What is the purpose of a CSR review?

The purpose of this review is to provide a framework for study team members, whether it’s for a large team that includes regulatory and administrative support or for smaller teams with only one or two members , for writing and organizing the CSR .

How many headings are there in a CSR?

Typically, the flow of your CSR will progress under six primary headings or sections, not unlike those used in a research manuscript. On the front end, even before the background and introduction, the document will include a title page, synopsis, table of contents, list of abbreviations, ethics statements, and details on the study’s administrative structure. The primary sections to come after that are highlighted in Figure 2 and summarized in turn below.

Why is patient narrative important?

Patient narratives are an important source of context for the reader of the CSR. Depending on your study, you may need to collaborate with either your teammates responsible for assessment of adverse events or the study database administrator to help generate patient and/or event narratives for the CSR.

Why do you need to include timelines in scope document?

Once you have determined your key stakeholders, you will want to determine timelines to ensure steady progress continues to be made on the document. If you’ve chosen to utilize a scope document, you’ll want to include these timelines in it, so the entire team is aware of the project process, the timing requirements, and each gating item (key gating items are summarized in Figure 1).

Is a clinical study team ethical?

Most likely you already appreciate the ethical responsibility a clinical study team has to clinical study data transparency, which for that reason alone would make the production of some sort of CSR necessary. Indeed, the preparation and representation of study progress is prescribed in the aforementioned ICH GCP E6 (R2) guideline, {1} which states that study sponsors should ensure that clinical trial reports are prepared and provided to regulatory agencies as they are required.

What is a clinical study report?

A clinical study report provides a clinical and statistical description, presentations and analyses of the completed study. The clinical study report should include an explanation of the critical design features, the plan, methods and conduct of the study, individual patient data and details of analytical methods.

How long does it take to submit a CSR?

In the European Union, sponsors must submit the CSR summary within one year of the end of their clinical trial to regulatory authorities and ethics committees. The results of most clinical trials are published in the EU clinical trials registry and are therefore accessible to the general public.

What is the purpose of the record of the receipt and dispensing of study products?

Records of the receipt and dispensing of study products were made to provide complete accountability of the disposition of all supplies. The investigational product accountability details are summarized in table below. Protocol No. C-CMP-SPl-001 Confidential Page 32 of64

Where are investigational products stored?

The pharmacist verified that the shipment contains all the items noted in the shipment inventory and also with respect to the COA of the Investigational Products in presence of Quality assurance personnel. The Investigational Products were stored in locked cabinets in the access controlled pharmacy, which is a secure area, at storage conditions as mentioned in the product label and as per in house SOPs. Access to Investigational Products was provided only to the pharmacist. The Investigational Products were dispensed as per the randomization scheme by the pharmacist in presence of Quality assurance personnel. The details of the study products are provided in the table below. Table 6: Identification of Investigational products

Where should clinical studies be submitted?

Clinical studies should be submitted to clinicaltrials.gov. Including the assigned number here is optional; remove this row if not applicable (N/A). NCTXXXXXXXX

What is a CSR template?

This Clinical Study Report (CSR) Template is specifically designed to be used in conjunction with the Clinical Study Protocol (CSP) Template. The structure and sections as well as their order and content follow the International Council for Harmonisation (ICH) E3 guidelines for CSRs, as recommended by the Food and Drug Administration (FDA). As such, this CSR Template is the foundation for an “integrated” full report of any study with a therapeutic, prophylactic, or diagnostic agent (i.e., drug or treatment) conducted in patients or healthy volunteers. Note that, if conducting a study with healthy volunteers, these may be referred to as “subjects” instead of “patients”, except where subjects have become patients due to adverse events (AEs). Per the ICH guidelines, the clinical and statistical description, presentation, and analyses are to be integrated into a single report (i.e., the CSR), incorporating tables and figures into the main text of the CSR or at the end of the text, with appendices containing such information as the CSP, sample case report forms (CRFs), investigator-related information, information related to the test drugs/investigational products (also referred to as study products), including active control/comparators, technical statistical documentation, related publications, patient data listings, and technical statistical details, such as derivations, computations, analyses, and computer output. Note that the CSR of a study should notbe created by simply joining a separate clinical and statistical report. Although this CSR Template is mainly developed for the most common efficacy and safety clinical studies (also referred to as clinical trials), the basic principles and structure can be applied to other kinds of studies, such as clinical pharmacology studies (e.g., pharmacokinetic [PK] or biomarker of exposure [BOE] studies). Depending on the nature and importance of such studies, a less detailed report might be acceptable. ● For more information on ICH guidelines for CSRs, visit https://www.ich.org/page/efficacy-guidelines

Can you copy the summary and conclusion of a study?

The majority of information (except Summary and Conclusions, Study Outcome and Conclusions) can be copied from the Clinical Study Protocol (CSP) (converted to past tense) to complete the table below. The Summary and Conclusions, and its subsections can be copied from the respective sections of the completed CSR. Per ICH guidelines, a brief synopsis (usually limited to no more than 3 pages) that summarizes the study should be provided. The synopsis should include numerical data to illustrate results (not just text or p-values).

What is a patient information sheet?

The patient information sheet detailed the procedures involved in the study (aims, methodology. potential risks, anticipated benefits) and the investigator explained these to each patient. The patient signed the consent form to indicate that the information had been explained and understood. The patient was then allowed time to consider the information presented before signing and dating the informed consent form to indicate that they fully understood the information, and willingly volunteered to participate in the study. The patient was given a copy of the informed consent form for their information. The original copy of the informed consent was kept in a confidential file in the Investigators centre records. A sample of the patient information sheet and consent form can be found at appendix [insert]

Who reviewed the study protocol?

The study protocol and all its amendments, and the patient information sheet(s) were reviewed and approved by the appropriate independent ethics committees as detailed in table one below.

Background

See more on acrpnet.org

Templates

Determining Stakeholders

Determining timelines

at Last…The Writing!

Review Process

Conclusion

References