Documentation in Clinical Research

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.

Fullscreen Download

Tags:

Documentation

Information

Domain:

Source:

Link to this page:

Please notify us if you found a problem with this document:

Other abuse

Transcription of Documentation in Clinical Research

Documents from same domain

Clinical Data Management - National Cancer Institute

ccrod.cancer.gov

Introduction • Clinical data management (CDM) consists of various activities involving the handling of data or information that is outlined in the protocol to be

Management, Data, Clinical, Clinical data management

Documenting, Recording, and Reporting of Adverse Events ...

ccrod.cancer.gov

an abnormal laboratory finding), symptom, or disease having been absent at baseline, or, if present at baseline, appears to worsen AND is temporally associated with medical treatment or procedure, REGARDLESS of the attribution (i.e., relationship of event to medical treatment or procedure). Adverse Event: FDA Definition

Reporting, Recording, Documenting, Abnormal, And reporting of

Introduction Documenting, Recording, and Reporting of ...

ccrod.cancer.gov

attribution (i.e., relationship of event to medical treatment or procedure). Adverse Event: FDA Definition FDA defines an adverse events as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Purposes of Adverse Event Monitoring The purposes of AE surveillance, especially

Events, Monitoring, Adverse, Adverse event, Adverse event monitoring

Monitoring & Auditing of Clinical Trials

ccrod.cancer.gov

•the progress of a clinical trial •safety data •critical efficacy variables ... (enter this visit on the site visit log) •Review Regulatory Binder ... •Assure all participant original consents are in the medical record, signed & dated •Note, original consents are sent to medical ...

Progress, Participant

Roles & Responsibilities of the Research Team & Sponsors

ccrod.cancer.gov

All staff involved in clinical research must adhere to the regulations and understand the guidelines that govern clinical ... human subjects research studies. ... –Protecting the rights, safety , and welfare of study subjects

Research, Team, Human, Roles, Subject, Protecting, Responsibilities, Involved, Roles amp responsibilities of the research team, Human subjects research

Objectives Roles & Responsibilities of the Sponsor

ccrod.cancer.gov

Roles & Responsibilities of the Sponsor Sponsored by Center for Cancer Research National Cancer Institute Objectives Funding for clinical research comes from the federal government or the private sector. In addition to providing financial resources, some funding groups also provide the investigational agent. They are referred to as the Sponsor

Roles, Responsibilities, Sponsor, Roles amp responsibilities of the sponsor

CBER 101 - Overview of the IND Process

ccrod.cancer.gov

6 Pre-IND Meetings (21 CFR 312.82) Request must be submitted in writing (fax is fine) and should include: Description of product Description of clinical indication and approach Identification of purpose, objectives, and draft of specific questions Suggested dates and times for meeting Pre-IND meetings are scheduled within 60 days from receipt of request

Draft, Meeting