Period of enrollment or chart review covers? Age, Sex, Race, Diagnoses if appropriate. Assessment of Resources Indicate how investigator will ensure that the study: Has sufficient access to the study population Has sufficient time to conduct and complete the study Has adequate qualified staff members to conduct the study Facility is adequate to conduct the study Staff has been adequately trained on the protocol and their specific research related duties D.
Contact Streamlining Clinical Study Protocols and Reports Recent pharma initiatives have been established to help ensure that clinical study protocols and reports are always presented in a similar way, making for easier assimilation and assessment. This article discusses these initiatives, and outlines their key recommendations.
As we have seen in earlier articles in this magazine, ICH guidelines help ensure that the same critical types of information are included in appropriate clinical documentation including clinical study protocols [CSPs] and clinical study reports [CSRs]but they do not guarantee that this information is always presented in a similar way.
This means that regulatory reviewers have to interpret numerous documents about all kinds of medicines, which may differ not only because of their specific therapeutic area content requirements, but also because information requirements that are common across programmes are presented in different ways.
It is therefore difficult to gain a clear understanding of the data generated across an industry. The effort needed to extract and compare data from one programme to the next — even within a single therapeutic area — can be enormous.
Despite this, the reviewer must assess if each new drug would be a valuable addition to the existing armamentarium of medicines. Both aim to produce CSPs and CSRs of common structure and layout, with standard information in just one, consistent place.
They aim to simplify the review task enormously and improve transparency, making it immediately apparent if information is missing or incomplete. The goal is to save time in developing documents and in drug development generally, as writing teams dispense with discussing options for the structure of the standard elements of a particular document, and focus on content.
So is this a pipe dream? The TransCelerate group is a collaboration between industry stakeholders and regulators who had the idea of producing a definitive template for the CSP, regardless of the type of treatment or therapeutic area being studied.
Each company approaches CSP writing slightly differently: Where should details of the various parties involved in performing the clinical study appear — in an appendix, at the front or somewhere in the middle?
As long as the information is there, its location is immaterial — as evidenced by the fact that CSPs are approved and the studies run, despite all this variation.
So why not agree on one approach, and use the time saved to focus on other, more important things? Training medical writers would be less time-consuming; writing and review time would also be shortened. At a minimum, it offers a model CSP template defining a common structure and standardised language.
Its intended use with libraries of common language in areas specific to patient populations and therapeutic areas means that the pre-crafted text proposals for many sections will be the same across CSPs.
Ultimately, the industry can save the time spent pondering redundancies and instead focus on study-specific content. Coauthor and end user review will be streamlined as familiarity with these standardised texts grows.
Investigators and study staff will more readily find the information they need, which may translate to efficiencies in terms of study performance.
The CPT is a detailed protocol template, including pre-prepared headings and draft text, in Microsoft Word format. It is intended to be used directly by authors of CSPs for any kind of clinical study, involving any kind of medical condition or therapy. The goal is that al protocols present equivalent information in a similar manner.Identify the reason(s) for writing the letter.
In writing an employee warning letter, you have to directly relay the reason to the employee. Is it about his or her poor performance, absenteeism, misconduct, or other violations of the company’s code of ethics.
This template is intended for protocols that don't involve research per se other than to collect data or biospecimens for research in the future.
When the information collected is limited to data, this is considered a Registry and collections of biospecimens with or without accompanying data are considered a . Oct 12, · An implementation research grant should cite service system research that demonstrates unmet need, the wide variation in the use of evidence-based treatments in usual care , or the association between the burden of disease and variations in the use of guidelines.
This template may be copied and used for any research or teaching project subject to quoting the source. This template is designed to assist researchers to put together a project proposal.
A good proposal should address or provide information on each of the elements outlined below. 1 Guidelines for Project Proposals* A technical proposal, often called a "Statement of Work,” is a persuasive document. Its objectives are to. The first step in writing a protocol is to decide on the appropriate study design to address the research question.
Clinical research is either experimental or observational. Clinical research is either experimental or observational.