Dr Bhatt-Study Startup-ACE05

8/7/2019 Dr Bhatt-Study Startup-ACE05

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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


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Sources of Delay in a Clinical Trial

0%

10%

20%30%

40%

50%

60%

70%

80%

90%

100%

Patient recruitment

Logistics

Data collection

Analysis Report


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Study Start Up Activities

Approvals

Budget

Contract

Documents

Essential supplies


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Study Start Activities

Protocol CRF

Regulatory andEthical Approval

Trial Documents Essential Supplies

SelectInvestigators

Site initiation visitsBudget Contracts


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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 Investigators Brochure

Relevant IND information Proof of payment Application for Import License Detailed calculation of quantity of drugs to be imported from

which country


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SCHEDULE Y Amended 2005Data To Be Submitted Along With The Application

To Conduct Clinical Trials1. 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 trialapplication)

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.


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To Conduct Clinical Trials3. 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 Studies4.5. Local toxicity

4.6. Allergenicity/Hypersensitivity

4.7. Genotoxicity

4.8. Carcinogenicity


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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 Phaseof trial)


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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 wheremarketed /approved

9.3. Free sale certificate or certificate of analysis, asappropriate.


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Other Regulatory Documents

Investigators brochure

Protocol

Case record form Informed consent document s

Patient information sheet with Informed consent

form with translation in 1-2 local languages.

Investigators undertaking (similar to FDA 1572) Ethics committee clearance, if available


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Export of Lab Samples

Covering letter to DGFT

Application for Export License

Import Export Code

Details of Laboratory Samples to be exported includingtotal quantity

Declaration from central laboratories for laboratory samples(including statement that the samples will not be used forgenetic manipulation)

List of tests/parameters to be performed on exportedsample

DCGI application for / approval of the protocol


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Documents for EC Approval

a) Trial Protocol( including protocol amendments),dated____________ Version no (s).__________

b) Patient Information Sheet and Informed Consent Form (includingupdates if any) in English and/or vernacular (local) language.

c) Investigators Brochure, dated_________, Version no.________d) Proposed methods for patient accrual including advertisement (s)

etc. proposed to be used for the purpose.

e) Principal Investigators current CV.

f) Insurance Policy / Compensation for participation and for seriousadverse events occurring during the study participation.

g) Investigators Agreement with the Sponsor

h) Investigators Undertaking


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EC Approval Letter

Dear Dr. ________

The Institutional Ethics Committee / Independent Ethics Committee (state name of the committee, asappropriate) 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 theprogress of the study, any SAE occurring in the course of the study, any changes in the protocol andpatient information/informed consent and asks to be provided a copy of the final report.

Yours sincerely,

Member Secretary, Ethics Committee.


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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, sourcedocument


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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


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Budget

5978Overhead 15%

45,878Per subject

39,850Total

16002008Subject time

40005008CoordinatorTime

16,00020008Investigatortime

3001003X ray

4501503ECG

16,00020008Lab

15005003Examination

Total cost RsCost Rs / visitNo of VisitsActivity


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ICH GCP : Contract

A written, dated, and signed agreement between

two or more involved parties that sets out any

arrangements on delegation and distribution oftasks and obligations and, if appropriate, on

financial matters.


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Major Contracts

Non Disclosure Agreement

Investigator undertaking/agreement

Clinical trial agreement Indemnity and insurance

Services contract


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Non Disclosure Agreement

PI and Sponsor

Protection of proprietary information

Binding on site staff Site responsibility


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Standard Clinical Trial Contract

Identification of protocol/ sponsor/institution/ investigator

Term & Termination notice

Payments & Schedule Confidentiality

Publication & Patents

Indemnification & Insurance

Subject injury

Applicable Law


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Indemnity/Insurance

Indemnity

Investigator, other staff and institute

Exceptions -Noncompliance/ Misconduct/negligence

Role of a CRO

Clinical trial insurance


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Study Initiation Documents

Investigators 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


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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


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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


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Study Start Up Activities Challenges

Internal

Regulatory

LegalFinance

Manufacture

External

Regulatory

InvestigatorSite administration

Ethics committee

Courier


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By failing to prepare you are preparing

to failBenjamin Franklin

The executive of the future will be

rated by his ability to anticipate his

problems rather than to meet them asthey come

Howard Coonely