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1. SUBJECT: MBAT
TOPIC: Ensure and documentation of GCP
karnataka college of pharmacy
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SUBMITTED TO:
DR.HARSHA K. TRIPATHY
PROFESSOR
DEPT. OF PHARMACEUTICAL ANALYSIS
KARNATAKA COLLEGE OF PHARMACY
BANGALORE
SUBMITTED BY:
S.GOKULRAJ
M PHARM 2nd SEMESTER
DEPT.OF PHARMACEUTICAL ANALYSIS
KARNATAKA COLLEGE OF PHARMACY
BANGALORE

2. Introduction to Good clinical practice
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DEFINITION:
 GCP is a standard for the design, conduct,
performance, monitoring, auditing, recording,
analyzing, and reporting of clinical trials that
provides assurance that the data and reported results
are credible and accurate and that the right,
integrity, and confidentiality of trial subjects are
protected.

3. Ensuring quality in clinical research
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 GCP aims to ensure that the studies are scientifically
authentic and that the clinical properties of the investigational
product are properly documented. GCP guidelines include
protection of human rights for the subjects and volunteers in a
clinical trial.
 GCP is an international ethical and scientific quality standard
for designing, conducting, recording, and reporting trials that
involve the participation of human patients.
 GCP guidelines include standards on how clinical trials should
be conducted, provide assurance of the safety of the newly
developed compounds, and focuses on the protection of
human rights in clinical trials

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It defines roles and responsibilities of:
IRB(institutional review boards):
 To safe guard the rights, safety, and well being of
all trials subjects. This done by initial, continuing
and annual review process. It should review all
documents given to participants. Maintenance of
records should be ensured.
Clinical research invigilators:
 should be familiar with investigation products and
their use, obtain informed consent from subjects.
Interact with patients and research team, show up
to date documents to IRB

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Clinical trial sponsors:
 trail management, data handling, record keeping, and
independent data monitoring committee which contain
qualified personnels to supervise overall conduct of the
study. They assesses the progress of the clinical trials,
maintain SOPS for electronic data processing.
Monitors (CRA's):
 provide assistance to investigators ensuring that the
trials is conducted ai documented properly, Helps in
coordinate meetings and information sharing

6. Why is it needed?
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 To ensure the rights, safety and well being of the trial
subjects are protected
 Ensure the credibility of clinical trial data

7. Documentation of Good clinical Practice
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Definition of document:
 Documentation is a practice concerned with all the
processes involved in transferring documents from
sources to users. The volume and variety of
documents are immense, and consequently
procedures of handling them are often pragmatic.
Nevertheless, principles emerge that may be
applied in practice.

8. Essential documentation
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 These essential documents serve to demonstrate the
compliance of the investigator, sponsor and monitor
with standards of good clinical practice and all
regulatory requirements
 Essential documents are those documents which
individually and collectively permit evaluation of the
trial and the quality of the data produced

9. The various Documents are grouped in Three
sections
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 According to the stage of the trial
1) Before the clinical phase of the trial starting.
2) During the clinical trial.
3) After completion or termination of the trial.
 We are going to look at what the investigator
/researcher needs to document.
 But, you also need to be aware that the trial
sponsor will also be obliged to keep a file

10. Trial File
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 It is good practice to dedicate the member of the
research staff for maintenance and updating of the
trial file.
 Filing of essential documents at the investigator /
institution and sponsor sites in a timely manner
can help in the smooth running of the trial.

11. Before the trial
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A)Investigator file:
The file will contain:
 Signed protocol or research proposal.
 Patient information sheet (blank).
 Patient consent form (blank).
 Advertisement for patient recruitment.
 Ethics approval documentation
 CVs of all team involved.
 Signature / delegation log.
 Clinical trial agreement.

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 Investigator's brochure provided by pharmaceutical
sponsor detailing relevant and current scientific
information about the investigational product.
 Normal values for medical / laboratory procedures and
tests.
 Lab accreditation certificates.
 Instructions and documentation for
handling/transporting of any trial medication and
related materials.
 Standard operating procedures (SOPs).
 Copies of questionnaires.
 Trial initiation report for sponsored studies.
 Master randomization list.

13. During the trial
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 Any protocol amendments.
 Any updates to investigator brochure, CRF, ethics documents.
 Signed patient consent forms.
 Notification of serious adverse events.
Subject identification log:
 Confidential for researcher only (each patient's address, date of birth, hospital
no).
Subject enrolment log:
 Documents enrolment of subject by trial number (subject not identified).
 Drug dispensing log.
 Drug accountability log

14. After completion of the trial
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 Final close-out monitoring reports.
 Decoding documentation.
 Complete subject id code list.
 Drug accountability and returns.
 Audit certificate.
 Final report to ethics.

15. Recording Data
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 Complete the CRF fully and legibly use a black pen.
 Any correction should be signed and dated with
comment (if necessary).
 The corrected data must be visible.
 The 1st place you write down data is the source
document (don't use scraps of paper).

16. Trial File and Archives
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 The investigator should setup study specific files in
which all appropriate documentation is filed.
 All study documents should be stored in safe, secure
and confidential environment.
 Treat source document as "gold" and ensure that
they don't get lost or destroyed.
 Keep for up to 15 years.
 Includes medical notes, X-rays, tissue samples and
CRFs.

17. Archiving
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 Archiving in clinical research relates to the collection of
essential documents, which permit the evaluation of
the trial and the quality of data produced for long-term
storage.
 It is the responsibility of the principle investigator to
arrange for the archiving of research data.
 When applicable, negotiate with the commercial
company a payment for the archiving of the site
documents as GCP facility.
 Once the study has ended, the investigator is obliged to
keep study-related documents for long period of time,
often as long as 15 years.

18. Good clinical practice
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 Compliance with ICH-GCP is essential for both
commercial and academic trails.
And Finally:
 If it is not written down, it didn't happen!!
 If it is not documented, it doesn't exist!!

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THANK YOU