Quality encompasses ‘subjective/perceived quality’ and ‘objective/technical quality’ and has been defined in varied ways as mentioned below: Degree of excellence – Oxford dictionary Fitness for purpose – Edward Deming The totality of characteristics of an entity that bear on its ability to satisfy stated or implied needs – ISO. There are lot of parameters by which quality in medical writing can be judged. The foremost is the quality of the content of the document that has ...
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An abstract is a concise summary of a research paper which highlights briefly all the important information. The abstract should be written only after the entire paper has been completed. Many journals where original research, systematic reviews, and meta-analyses are submitted require structured abstracts. The abstract should include the background and state the study's purpose, methods (selection of study participants, settings, study design, interventions/treatments, measurements, analytical methods), results (outcomes, giving specific effect sizes and their statistical and clinical significance), ...
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The informed consent form is the document that participants must sign before participating in a clinical research study and before any screening procedures are undertaken. The informed consent document should provide general information, study-specific information and in addition any specific national/regional regulatory requirement: The name of the clinical research study and its purpose A statement that the study involves research How long the study will last, how many participants will be enrolled Procedures that will be performed, and ...
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According to the International council for harmonization (ICH) E6 guidelines, the Investigator Brochure (IB) is a compilation of the clinical and non-clinical data on a product in development that are relevant to the study of the product(s) in human subjects. It is primarily written for investigators and other personnel involved in the execution of a clinical trial, also submitted to ethics committees and regulatory authorities. Its purpose is to provide the investigators and others stakeholders involved in the ...
Read more...The Europe General Data Protection Regulation (GDPR), effective from 25th May 2018, has replaced the Data Protection Directive 95/46/EC and has a legal framework that sets procedure for the collection and processing of personal information of individuals within the European Union. All subjects need to provide their informed consent before they can participate in a trial. The informed consent and clinical trials are regulated by the Clinical Trials Directive 2001/20/EC and the new Clinical Trials Regulation 536/2014/EU. Now, ...
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The unprecedented Britain’s exit from the European Union (EU), now commonly known as Brexit is scheduled on 30 March 2019; and is already causing lot of concerns and anxiety. In this blog, we have tried to explain few such general issues that affect clinical research and pharmaceutical industry and medical writing in particular. To understand the impact, it is good to know a bit about the background about what has been happening and what is scheduled to happen. ...
Read more...Writing a research protocol is probably one of the most challenging and difficult task in medical writing. Every clinical investigation begins with the development of a clinical protocol. Clinical research is conducted according to a plan (a protocol).The protocol provides the guidelines for conducting the trial- unmet need (background and rationale), why trial is carried out (objectives, questions that need to be answered), how and when it is carried out (eligibility of the participants, the length of ...
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Periodic Benefit Risk Evaluation Report (PBRER) provides a periodic, comprehensive, concise, and critical analysis of new or emerging information on the risks of the medicinal product, and on its benefit in approved indications, to enable an appraisal of the product’s overall benefit-risk profile. Guidelines are available from International Council for Harmonisation (ICH) Topic E2C (R2) and EU Good Pharmacovigilance Practices (GVP) - Module VII.Such reports are required because the data from clinical trials based on which the ...
Read more...The development safety update report (DSUR) is a harmonized, safety document covering the safety summary of medicinal products under development (including marketed drugs that are under further study) among the International Council for Harmonisation (ICH) regions (replacing US IND Annual Report and EU Annual Safety Report). The guideline for the same is in ICH E2F.DSUR focuses (before and after marketing authorization) on Clinical trials of investigational drugs (including vaccines and biologics), and Other findings that impact the ...
Read more...The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a joint initiative involving both regulators and pharmaceutical-based industry representatives of the US, EU, and Japan to have scientific and technical discussions for drug registration and testing procedures required to assess and ensure the safety, quality and efficacy of medicines.The ICH Efficacy (E) 3 is a harmonised ICH Guideline for Clinical Study Report (CSR) that was finalised in November 1995, which represents ...
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