Documentation In Research Example

Good example Documentation is available throughout the study and during the required time after study completion. For Investigational New Drug IND research, the Food and Drug Administration FDA requires that sponsors and investigators retain quotrecords and reports required by this part for 2 years after

When publishing research, it is important to make documentation available so that readers can understand the details of the research design that the work reports. This includes all of the technical details and decisions that could influence how the findings are read or understood. Usually, this will involve producing a document along the lines of a methodological note or appendix.

Examples and Observations . Adrienne Escoe quotDocumentation has many meanings, from the broadanything written in any mediumto the narrowpolicies and procedures manuals or perhaps records.quot The Practical Guide to People-Friendly Documentation, 2nd. ed. ASQ Quality Press, 2001Kristin R. Woolever quotAn issue more important than documentation form is knowing when to document.

Documentation can be maintained in a variety of forms. Some common forms of documentation are Readme - A Readme file is a text file located in a project-related folder that describes the contents and structure of the folder andor a dataset so that a researcher can locate the information they need.. Data Dictionary - Also known as a codebook, a data dictionary defines and describes the

Documentation in clinical practice is essential for communication among healthcare providers. It is from this documentation that protocol-specific data are abstracted from and transferred to case report forms CRFs. This module will outline appropriate clinical research practice documentation.

Study Documentation Templates and Tools. During planning and operationalization stages, before enrollment starts, research teams should discuss what forms will be needed for their study. These could be data collection forms, source documentation, even forms or logs for study management like visit checklists and progress notes.

The Department of Medicine Clinical Research Unit has prepared this document is to provide guidance to all faculty and staff involved in the conduct of research on the best practices related to documentation. Good study documentation will allow for an individual with basic knowledge of the particular project to recreate the events of the study.

Parenthetical Documentation Both MLA and APA do not recommend footnotes or endnotes to document sources. The bibliography, according to them, should contain only the works a writer has cited in the text and not the works consulted. They use parenthetical, or in --text, documentation. While the MLA style sheet uses quotWorks Cited,quot the APA

This example, illustrates a common occurrence in clinical trial research where a lack of understanding of basic GCP principles may have a negative impact on the quality of the study. WHAT IS THE PURPOSE OF SOURCE DOCUMENTATION? To understand the importance of good source documentation we should first review the purpose of source documentation.

Purpose The purpose of source documentation is to reconstruct the research study as it happened. It should allow for data to be confirmed, validated, and support the fundamental principle of protecting the participant's rights, safety and well-being. These templates are intended to assist in documenting study procedures, interventions, observations, etc. Below are several examples that