Current research is very rarely done by a single investigator and thus a scientific paper almost always has multiple authors. Writing an article with multiple collaborators can be chaotic and time consuming. Adopting a few of the principles that underlie document writing operating procedures used by pharmaceutical companies can simplify the process and expedite it. …
The International Conference on Harmonization Good Clinical Practice (ICH-GCP) defines the Sponsor of a clinical trial as an individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial. ICH-GCP lists more than 60 separate responsibilities for the Sponsor1. The benefits of outsourcing clinical development activities have been …
Data quality within the clinical research enterprise can be defined as the absence of errors that matter and assurance that the data is good enough to fit the purpose. Source document verification (SDV) is commonly used as a quality control method in clinical research. It is disproportionately expensive and often leads to questionable benefits. Its …
Clinical study data is defined by the FDA as information about a person in a clinical trial, that may include information, details of medical treatment, descriptions of the participant’s progress, and other relevant information. In early studies, this same information is captured for animals and is called nonclinical study data. The FDA requires that submission of IND …
The FDA has recently published a new version of the Technical Conformance Guide (TCG) with updates that impact regulatory data submissions. Technical Rejection Criteria Presenting the Technical Rejection Criteria is one of the introduced TCG updates. These criteria, to be applicable following a 30-day notice from the FDA, define several new requirements for data submissions. One of …
The SDSP (Study Data Standardization Plan) is a document intended to communicate to CDER (Center for Drug Evaluation and Research) and CBER (Center for Biological Evaluation and Research) the expected CDISC (SDTM, ADaM and SEND) standards used for data in upcoming clinical and pre-clinical trials. SDSP is used in early stages of the submission process, preferably …
SEND (Standard for Exchange of Nonclinical Data) is a means of implementing CDISC Standard Data Tabulation Model (SDTM) to represent nonclinical data. SEND standards are based on SDTM domains and variables and include datasets and variables common to the clinical world such as Vital Signs (VS) and Disposition (DS) as well as additional variables and domains that are …