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Full Answer

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

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

When you are presenting a patient whom you have presented very recently, will your presentation be much shorter?

When you are presenting a patient whom you have presented very recently (such as on daily rounds on an inpatient service), your presentation will be much shorter, more focused, and generally only include what is new, changed, or updated as follows:#N#

What is summary statement?

The summary statement is essentially the "opening argument" of what diagnosis (or diagnoses) you think are most likely and primes your audience for why this is the case by providing evidence. While the beginning (including demographics and relevant PMH) mirrors the opening statement of your HPI, it should include more information.#N#

Why is oral presentation important?

The oral presentation is a critically important skill for medical providers in communicating patient care wither other providers. It differs from a patient write-up in that it is shorter and more focused, providing what the listeners need to know rather than providing a comprehensive history that the write-up provides.#N#

Do you need to include a review of systems in HPI?

Don't: Do not need include a review of systems in most cases. If the pieces of ROS were relevant, they should have been in your HPI. If they aren't relevant, don't include them in your presentation at all.#N#