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Study Start Up Activities

Dr Arun Bhatt MD (Med) FICP (Ind)

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

Trial Documents • Essential Supplies


Select
Investigators

Budget Contracts Site initiation visits


Regulatory Application

• Covering Letter to DCGI


• Application Form 44
• List of countries where the study has been approved and copy of
the approval letters
• List of Investigators
• Undertaking by Investigator
• Current protocol with Signature Pages
• PIS/ICF in local languages
• CRF
• Investigator’s Brochure
• Relevant IND information
• Proof of payment
• Application for Import License
• Detailed calculation of quantity of drugs to be imported from
which country
SCHEDULE Y Amended 2005
Data To Be Submitted Along With The Application
To Conduct Clinical Trials

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

4. Animal Toxicology (as applicable for relevant Phase of trial)


4.1. General Aspects
4.2. Systemic Toxicity Studies
4.3. Male Fertility Study
4.4. Female Reproduction and Developmental Toxicity Studies
4.5. Local toxicity
4.6. Allergenicity/Hypersensitivity
4.7. Genotoxicity
4.8. Carcinogenicity
SCHEDULE Y Amended 2005
Data To Be Submitted Along With The Application
To Conduct Clinical Trials

5. Human / Clinical pharmacology (Phase I)


6. Therapeutic exploratory trials (Phase II)
7. Therapeutic confirmatory trials (Phase III)
8. Special studies
8.1. Summary
8.2. Bio-availability / Bio-equivalence.
8.3 Other studies e.g. geriatrics, paediatrics,
pregnant or nursing women (If relevant to Phase
of trial)
SCHEDULE Y Amended 2005
Data To Be Submitted Along With The Application
To Conduct Clinical Trials

9. Regulatory status in other countries


9.1. Countries where the drug is
a. Marketed
b. Approved
c. Approved as IND
d. Withdrawn, if any, with reasons
9.2. Restrictions on use, if any, in countries where
marketed /approved
9.3. Free sale certificate or certificate of analysis, as
appropriate.
Other Regulatory Documents

• 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

• Covering letter to DGFT


• Application for Export License
• Import Export Code
• Details of Laboratory Samples to be exported including
total quantity
• Declaration from central laboratories for laboratory samples
(including statement that the samples will not be used for
genetic manipulation)
• List of tests/parameters to be performed on exported
sample
• DCGI application for / approval of the protocol
Documents for EC Approval

a) Trial Protocol( including protocol amendments),


dated____________ Version no (s).__________
b) Patient Information Sheet and Informed Consent Form (including
updates if any) in English and/or vernacular (local) language.
c) Investigator’s Brochure, dated_________, Version no.________
d) Proposed methods for patient accrual including advertisement (s)
etc. proposed to be used for the purpose.
e) Principal Investigator’s current CV.
f) Insurance Policy / Compensation for participation and for serious
adverse events occurring during the study participation.
g) Investigator’s Agreement with the Sponsor
h) Investigator’s Undertaking
EC Approval Letter

Dear Dr. ________

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 documents were reviewed:

The following members of the ethics committee were present at the meeting held on (date, time, place).

__________ Chairman of the Ethics Committee


__________ Member secretary of the Ethics Committee
__________ Name of each member with designation

We approve the trial to be conducted in its presented form.

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,

Member Secretary, Ethics Committee.


Study Subject Budget Checklist

• Clinical Activities rates - procedures, lab fees,


radiology, admission, pharmacy
• Personnel hours / fee - physician, coordinator,
technical, clerical
• Study charges - Ethics committee, equipment,
record storage, advertisements, training, source
document
Study Budget Checklist

• Subject Payment amounts & times - travel, meals,


compensation
• Subject costs - per screened, per dropped
• Management charges - pharmacy (storage &
preparation of drug), SAE processing
• Administrative charges - overhead %,
cancellation fee
Budget
Activity No of Visits Cost Rs / visit Total cost Rs
Examination 3 500 1500
Lab 8 2000 16,000
ECG 3 150 450
X ray 3 100 300
Investigator 8 2000 16,000
time
Coordinator 8 500 4000
Time
Subject time 8 200 1600
Total 39,850
Overhead 15% 5978
Per subject 45,878
ICH GCP : Contract

A written, dated, and signed agreement between


two or more involved parties that sets out any
arrangements on delegation and distribution of
tasks and obligations and, if appropriate, on
financial matters.
Major Contracts

• Non Disclosure Agreement


• Investigator undertaking/agreement
• Clinical trial agreement
• Indemnity and insurance
• Services contract
Non Disclosure Agreement

• 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

• Clinical trial insurance


Study Initiation Documents

• 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

• Medical / lab/ technical procedures/ tests


• Normal values
• Label for clinical trial samples
• Instruction for handling samples
• Shipping records for investigational product (s)
• Certificate of analysis of investigational product
• Decoding procedures
• Master randomization list
• Pre-trial monitoring report
• Trial initiation monitoring report
Essential Supplies

• Study documents – protocol, CRF, ICF


• Forms & Logs – SAE, Drug accountability
• Investigational product – drug / placebo
• Instructions – drug / lab sample storage
• Stationary - files, black ball pen, paper
• Storage – cupboard, fridge
Study Start Up Activities – Challenges

Internal External
•Regulatory •Regulatory
•Legal •Investigator
•Finance •Site administration
•Manufacture •Ethics committee
•Courier
By failing to prepare you are preparing
to fail
Benjamin Franklin

The executive of the future will be


rated by his ability to anticipate his
problems rather than to meet them as
they come
Howard Coonely

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