The document discusses essential documents for clinical trials. Essential documents are those needed before, during, or after a clinical trial to permit evaluation of the trial conduct and quality of the data produced. They must meet Good Clinical Practice standards and regulatory requirements. There are four sections that classify essential documents: Section 1 provides an introduction; Section 2 covers documents needed before a trial commences; Section 3 covers documents needed during trial conduct; and Section 4 covers documents needed after trial completion or termination.

1. RamkrisnaBhunjawa
M.Sc. Clinical Research,
Chettinad University
Chennai, Tamil Nadu.
Date: 12/11/2012
ramkrisna1591@gmail.com

3. Ans: Essentiality is the
need or compulsion that
can not be avoided
Or ignored.

4. Q: What is ‘essential document’?

5. • Ans: In any work or process
documents that are needed before
initiation ,between or generally end
of the process just like in a clinical
trial those Documents Which
Permits Evaluation Of The
Conduct Of A Trial And The
Quality Of The Data Produced. It
Is Given In ‘8’ Sec. Of ICH-GCP.

6. These documents are fulfilled with
all standards of ‘GCP’ and
applicable regulatory requirements.
These have to be used several other
purpose to.Thuse documents are
often audited by regulatory
authority. Essential documents are
the milestone of the clinical trial.

7. These are classified in 4 sec.
1. Introduction
2. Before the Clinical Phase of the Trial
Commences
3. During the Clinical Conduct of the
Trial
4. After Completion or Termination of
the Trial

8.  Sec.1- Introduction
It is all about the document importance and as
we know some general information of it.
 Sec. 2- Before the Clinical Phase of the Trial
Commences :
It contains ’20’ documents.
 Sec. 3- During the Clinical Conduct of the Trial
It contains ‘25’ documents that are necessary during the
trial/study.
 Sec. 4- After Completion or Termination of the Trial
It contains ‘8’ documents.