Escolar Documentos
Profissional Documentos
Cultura Documentos
Member
Faculty of Pharmaceutical Medicine
President
ClinInvent Research Pvt Ltd
Sources of Delay in a Clinical Trial
100%
90% Patient recruitment
80%
70%
60% Logistics
50%
40%
Data collection
30%
20%
Analysis Report
10%
0%
Study Start Up Activities
Approvals
Budget
Contract
Documents
Essential supplies
Study Start Activities
Protocol • CRF
Regulatory and
Ethical Approval
1. Introduction
A brief description of the drug and the therapeutic class to which it belongs.
2. Chemical and pharmaceutical information
2.1. Information on active ingredients
2.2. Physicochemical Data
2.3. Analytical Data
2.4. Complete monograph specification (not required for clinical trial
application)
2.5. Validations (not required for clinical trial application)
2.6. Stability Studies
2.7. Data on Formulation
When the application is for clinical trials only, the international non-
proprietary name (INN) or generic name, drug category, dosage form and data
supporting stability in the intended container-closure system for the duration
of the clinical trial (information covered in item nos. 2.1, 2.3, 2.6, 2.7) are
required.
SCHEDULE Y Amended 2005
Data To Be Submitted Along With The Application
To Conduct Clinical Trials
3. Animal Pharmacology
3.1. Summary
3.2. Specific pharmacological actions
3.3. General pharmacological actions
3.4. Follow-up and Supplemental Safety Pharmacology Studies
3.5. Pharmacokinetics: absorption, distribution; metabolism; excretion
• Investigator’s brochure
• Protocol
• Case record form
• Informed consent document s
• Patient information sheet with Informed consent
form with translation in 1-2 local languages.
• Investigator’s undertaking (similar to FDA 1572)
• Ethics committee clearance, if available
Export of Lab Samples
The Institutional Ethics Committee / Independent Ethics Committee (state name of the committee, as
appropriate) reviewed and discussed your application to conduct the clinical trial entitled “……” on
…….(date).
The following members of the ethics committee were present at the meeting held on (date, time, place).
The Institutional Ethics Committee / Independent Ethics Committee expects to be informed about the
progress of the study, any SAE occurring in the course of the study, any changes in the protocol and
patient information/informed consent and asks to be provided a copy of the final report.
Yours sincerely,
• PI and Sponsor
• Protection of proprietary information
• Binding on site staff
• Site responsibility
Standard Clinical Trial Contract
• Identification of protocol/ sponsor/
institution/ investigator
• Term & Termination notice
• Payments & Schedule
• Confidentiality
• Publication & Patents
• Indemnification & Insurance
• Subject injury
• Applicable Law
Indemnity/Insurance
• Indemnity
– Investigator, other staff and institute
– Exceptions -Noncompliance/ Misconduct/
negligence
– Role of a CRO
• Investigator’s brochure
• Signed protocol & amendments, CRF
• Information for subject - consent, advertisement
• Financial aspects
• Insurance statement
• Signed agreement between involved parties
• Dated, documented approval of ethics committee
• Composition of ethics committee
• Regulatory approval
• CV of investigators / team
Study Initiation Documents
Internal External
•Regulatory •Regulatory
•Legal •Investigator
•Finance •Site administration
•Manufacture •Ethics committee
•Courier
By failing to prepare you are preparing
to fail
Benjamin Franklin