D R D E E P A K L A N G A D EM B B S M D P G D A S S ( A P P L I E D S T A T I S T I C S )

A S S O P R O F I N P H A R M A C O L O G Y

B V D U D C amp H N A V I M U M B A I

Research Methodology[Session ndash III]

Research Methods Biostatistics

16022015 1405Research Methodology DrDeepak Langade

1 Basics of Research Methodology

2 Study designs

3 Study documentation

4 Regulatory amp legal aspects of biomedical research

5 Introduction to Statistics amp Biostatistics

6 Sample size estimation for research

7 Hypothesis testing amp Applied Biostatistics

8 Presentation of data and reading the data

2

Schedule of Program

Essential Documents in Biomedical Research

Contents

16022015 1405Research Methodology DrDeepak Langade

4

Essential Documents

Documents before start of study

Documents during study

Documents after completion of study

Responsibilities of Investigator

Case Record Form (CRF)

Informed Consent Process

Essential Documents

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

6

Essential

Absolutely necessary indispensable fundamental basic

or constituting the essence of a person or a thing

Document

A piece of written or printed matter that provides a record or evidence of eventsan agreement ownership identification (evidence to record)

Essential Documents

Research Methodology DrDeepak Langade

7

Definitions (ICH ndashGCP)

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced

Definitions(INDIAN GCP)

The Documents that permit evaluation of a study and the quality of the data generated

16022015 1405

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

8

Role of Essential Documents

These documents serve to demonstrate the compliance of the investigator and research team with the standards of Good Clinical Practice and with all applicable regulatory requirements

Could be subjected to

Audit

Inspection

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

9

Before start of study

During study

After study completion

Documents before start of the Study

Documents before start of studySection 82 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

11

Documents

Research protocol with amendments

Protocol synopsis

CRF DCF

Investigator Brochure (IB)

Informed consent document (ICD)

Patient information sheet (PIS)

Informed consent form (ICF)

Any advertisements communication for patients public

Financial aspects of the study

Research Methods Biostatistics

16022015 1405Research Methodology DrDeepak Langade

1 Basics of Research Methodology

2 Study designs

3 Study documentation

4 Regulatory amp legal aspects of biomedical research

5 Introduction to Statistics amp Biostatistics

6 Sample size estimation for research

7 Hypothesis testing amp Applied Biostatistics

8 Presentation of data and reading the data

2

Schedule of Program

Essential Documents in Biomedical Research

Contents

16022015 1405Research Methodology DrDeepak Langade

4

Essential Documents

Documents before start of study

Documents during study

Documents after completion of study

Responsibilities of Investigator

Case Record Form (CRF)

Informed Consent Process

Essential Documents

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

6

Essential

Absolutely necessary indispensable fundamental basic

or constituting the essence of a person or a thing

Document

A piece of written or printed matter that provides a record or evidence of eventsan agreement ownership identification (evidence to record)

Essential Documents

Research Methodology DrDeepak Langade

7

Definitions (ICH ndashGCP)

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced

Definitions(INDIAN GCP)

The Documents that permit evaluation of a study and the quality of the data generated

16022015 1405

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

8

Role of Essential Documents

These documents serve to demonstrate the compliance of the investigator and research team with the standards of Good Clinical Practice and with all applicable regulatory requirements

Could be subjected to

Audit

Inspection

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

9

Before start of study

During study

After study completion

Documents before start of the Study

Documents before start of studySection 82 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

11

Documents

Research protocol with amendments

Protocol synopsis

CRF DCF

Investigator Brochure (IB)

Informed consent document (ICD)

Patient information sheet (PIS)

Informed consent form (ICF)

Any advertisements communication for patients public

Financial aspects of the study

Essential Documents in Biomedical Research

Contents

16022015 1405Research Methodology DrDeepak Langade

4

Essential Documents

Documents before start of study

Documents during study

Documents after completion of study

Responsibilities of Investigator

Case Record Form (CRF)

Informed Consent Process

Essential Documents

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

6

Essential

Absolutely necessary indispensable fundamental basic

or constituting the essence of a person or a thing

Document

A piece of written or printed matter that provides a record or evidence of eventsan agreement ownership identification (evidence to record)

Essential Documents

Research Methodology DrDeepak Langade

7

Definitions (ICH ndashGCP)

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced

Definitions(INDIAN GCP)

The Documents that permit evaluation of a study and the quality of the data generated

16022015 1405

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

8

Role of Essential Documents

These documents serve to demonstrate the compliance of the investigator and research team with the standards of Good Clinical Practice and with all applicable regulatory requirements

Could be subjected to

Audit

Inspection

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

9

Before start of study

During study

After study completion

Documents before start of the Study

Documents before start of studySection 82 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

11

Documents

Research protocol with amendments

Protocol synopsis

CRF DCF

Investigator Brochure (IB)

Informed consent document (ICD)

Patient information sheet (PIS)

Informed consent form (ICF)

Any advertisements communication for patients public

Financial aspects of the study

Contents

16022015 1405Research Methodology DrDeepak Langade

4

Essential Documents

Documents before start of study

Documents during study

Documents after completion of study

Responsibilities of Investigator

Case Record Form (CRF)

Informed Consent Process

Essential Documents

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

6

Essential

Absolutely necessary indispensable fundamental basic

or constituting the essence of a person or a thing

Document

A piece of written or printed matter that provides a record or evidence of eventsan agreement ownership identification (evidence to record)

Essential Documents

Research Methodology DrDeepak Langade

7

Definitions (ICH ndashGCP)

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced

Definitions(INDIAN GCP)

The Documents that permit evaluation of a study and the quality of the data generated

16022015 1405

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

8

Role of Essential Documents

These documents serve to demonstrate the compliance of the investigator and research team with the standards of Good Clinical Practice and with all applicable regulatory requirements

Could be subjected to

Audit

Inspection

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

9

Before start of study

During study

After study completion

Documents before start of the Study

Documents before start of studySection 82 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

11

Documents

Research protocol with amendments

Protocol synopsis

CRF DCF

Investigator Brochure (IB)

Informed consent document (ICD)

Patient information sheet (PIS)

Informed consent form (ICF)

Any advertisements communication for patients public

Financial aspects of the study

Essential Documents

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

6

Essential

Absolutely necessary indispensable fundamental basic

or constituting the essence of a person or a thing

Document

A piece of written or printed matter that provides a record or evidence of eventsan agreement ownership identification (evidence to record)

Essential Documents

Research Methodology DrDeepak Langade

7

Definitions (ICH ndashGCP)

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced

Definitions(INDIAN GCP)

The Documents that permit evaluation of a study and the quality of the data generated

16022015 1405

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

8

Role of Essential Documents

These documents serve to demonstrate the compliance of the investigator and research team with the standards of Good Clinical Practice and with all applicable regulatory requirements

Could be subjected to

Audit

Inspection

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

9

Before start of study

During study

After study completion

Documents before start of the Study

Documents before start of studySection 82 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

11

Documents

Research protocol with amendments

Protocol synopsis

CRF DCF

Investigator Brochure (IB)

Informed consent document (ICD)

Patient information sheet (PIS)

Informed consent form (ICF)

Any advertisements communication for patients public

Financial aspects of the study

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

6

Essential

Absolutely necessary indispensable fundamental basic

or constituting the essence of a person or a thing

Document

A piece of written or printed matter that provides a record or evidence of eventsan agreement ownership identification (evidence to record)

Essential Documents

Research Methodology DrDeepak Langade

7

Definitions (ICH ndashGCP)

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced

Definitions(INDIAN GCP)

The Documents that permit evaluation of a study and the quality of the data generated

16022015 1405

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

8

Role of Essential Documents

These documents serve to demonstrate the compliance of the investigator and research team with the standards of Good Clinical Practice and with all applicable regulatory requirements

Could be subjected to

Audit

Inspection

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

9

Before start of study

During study

After study completion

Documents before start of the Study

Documents before start of studySection 82 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

11

Documents

Research protocol with amendments

Protocol synopsis

CRF DCF

Investigator Brochure (IB)

Informed consent document (ICD)

Patient information sheet (PIS)

Informed consent form (ICF)

Any advertisements communication for patients public

Financial aspects of the study

Essential Documents

Research Methodology DrDeepak Langade

7

Definitions (ICH ndashGCP)

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced

Definitions(INDIAN GCP)

The Documents that permit evaluation of a study and the quality of the data generated

16022015 1405

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

8

Role of Essential Documents

These documents serve to demonstrate the compliance of the investigator and research team with the standards of Good Clinical Practice and with all applicable regulatory requirements

Could be subjected to

Audit

Inspection

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

9

Before start of study

During study

After study completion

Documents before start of the Study

Documents before start of studySection 82 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

11

Documents

Research protocol with amendments

Protocol synopsis

CRF DCF

Investigator Brochure (IB)

Informed consent document (ICD)

Patient information sheet (PIS)

Informed consent form (ICF)

Any advertisements communication for patients public

Financial aspects of the study

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

8

Role of Essential Documents

These documents serve to demonstrate the compliance of the investigator and research team with the standards of Good Clinical Practice and with all applicable regulatory requirements

Could be subjected to

Audit

Inspection

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

9

Before start of study

During study

After study completion

Documents before start of the Study

Documents before start of studySection 82 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

11

Documents

Research protocol with amendments

Protocol synopsis

CRF DCF

Investigator Brochure (IB)

Informed consent document (ICD)

Patient information sheet (PIS)

Informed consent form (ICF)

Any advertisements communication for patients public

Financial aspects of the study

Essential Documents

16022015 1405Research Methodology DrDeepak Langade

9

Before start of study

During study

After study completion

Documents before start of the Study

Documents before start of studySection 82 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

11

Documents

Research protocol with amendments

Protocol synopsis

CRF DCF

Investigator Brochure (IB)

Informed consent document (ICD)

Patient information sheet (PIS)

Informed consent form (ICF)

Any advertisements communication for patients public

Financial aspects of the study

Documents before start of the Study

Documents before start of studySection 82 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

11

Documents

Research protocol with amendments

Protocol synopsis

CRF DCF

Investigator Brochure (IB)

Informed consent document (ICD)

Patient information sheet (PIS)

Informed consent form (ICF)

Any advertisements communication for patients public

Financial aspects of the study

Documents before start of studySection 82 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

11

Documents

Research protocol with amendments

Protocol synopsis

CRF DCF

Investigator Brochure (IB)

Informed consent document (ICD)

Patient information sheet (PIS)

Informed consent form (ICF)

Any advertisements communication for patients public

Financial aspects of the study

Documents before start of studySection 82 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

12

Documents contdhellip

Agreements

Insurance

EC IRB approvals (favorable)

Composition of EC IRB

CV Biodata of Research team

Normal reference range of investigations

Medical Dental Laboratory Technical procedures

CTRI Registration

Documents before start of studySection 82 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

13

Documents contdhellip

Sample labels for IP

Instructions for handling IPtools

IP (COA Batch no make mfg expiry)

Blinding procedures

Decoding procedures

Master randomization chart

Regulatory approvals

DCGI

DGFT

Documents during the Study

Documents during the studySection 83 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

15

Additional Documents

IB updates

Revisions of protocol or other documents

Updates to reference ranges tools procedures

Relevant communication with other parties involved

Source documents

CRFs (completed signed amp dated)

Safety data (adverse events serious adverse events)

Documents during the studySection 83 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

16

Additional Documents contdhellip

Interim analysis

Subject screening amp enrollment log

Subject identification code

IP accountability

Signed amp dated ICD

Record of patient samplestissuesfluid etc

Documents after completion of the Study

Documents after study completionSection 84 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

18

Additional Documents

IB updates

Relevant communication with other parties involved

Source documents

CRFs (completed signed amp dated)

Safety data (adverse events serious adverse events)

IP destruction

Documents after study completionSection 84 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

19

Additional Documents

Completed subjects ID code list

Audit certificate

Treatment allocation amp decoding documentation

Final study report

Documents during the Study

Documents during the studySection 83 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

15

Additional Documents

IB updates

Revisions of protocol or other documents

Updates to reference ranges tools procedures

Relevant communication with other parties involved

Source documents

CRFs (completed signed amp dated)

Safety data (adverse events serious adverse events)

Documents during the studySection 83 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

16

Additional Documents contdhellip

Interim analysis

Subject screening amp enrollment log

Subject identification code

IP accountability

Signed amp dated ICD

Record of patient samplestissuesfluid etc

Documents after completion of the Study

Documents after study completionSection 84 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

18

Additional Documents

IB updates

Relevant communication with other parties involved

Source documents

CRFs (completed signed amp dated)

Safety data (adverse events serious adverse events)

IP destruction

Documents after study completionSection 84 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

19

Additional Documents

Completed subjects ID code list

Audit certificate

Treatment allocation amp decoding documentation

Final study report

Documents during the studySection 83 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

15

Additional Documents

IB updates

Revisions of protocol or other documents

Updates to reference ranges tools procedures

Relevant communication with other parties involved

Source documents

CRFs (completed signed amp dated)

Safety data (adverse events serious adverse events)

Documents during the studySection 83 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

16

Additional Documents contdhellip

Interim analysis

Subject screening amp enrollment log

Subject identification code

IP accountability

Signed amp dated ICD

Record of patient samplestissuesfluid etc

Documents after completion of the Study

Documents after study completionSection 84 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

18

Additional Documents

IB updates

Relevant communication with other parties involved

Source documents

CRFs (completed signed amp dated)

Safety data (adverse events serious adverse events)

IP destruction

Documents after study completionSection 84 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

19

Additional Documents

Completed subjects ID code list

Audit certificate

Treatment allocation amp decoding documentation

Final study report

Documents during the studySection 83 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

16

Additional Documents contdhellip

Interim analysis

Subject screening amp enrollment log

Subject identification code

IP accountability

Signed amp dated ICD

Record of patient samplestissuesfluid etc

Documents after completion of the Study

Documents after study completionSection 84 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

18

Additional Documents

IB updates

Relevant communication with other parties involved

Source documents

CRFs (completed signed amp dated)

Safety data (adverse events serious adverse events)

IP destruction

Documents after study completionSection 84 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

19

Additional Documents

Completed subjects ID code list

Audit certificate

Treatment allocation amp decoding documentation

Final study report

Documents after completion of the Study

Documents after study completionSection 84 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

18

Additional Documents

IB updates

Relevant communication with other parties involved

Source documents

CRFs (completed signed amp dated)

Safety data (adverse events serious adverse events)

IP destruction

Documents after study completionSection 84 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

19

Additional Documents

Completed subjects ID code list

Audit certificate

Treatment allocation amp decoding documentation

Final study report

Documents after study completionSection 84 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

18

Additional Documents

IB updates

Relevant communication with other parties involved

Source documents

CRFs (completed signed amp dated)

Safety data (adverse events serious adverse events)

IP destruction

Documents after study completionSection 84 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

19

Additional Documents

Completed subjects ID code list

Audit certificate

Treatment allocation amp decoding documentation

Final study report

Documents after study completionSection 84 ICH-GCP

16022015 1405Research Methodology DrDeepak Langade

19

Additional Documents

Completed subjects ID code list

Audit certificate

Treatment allocation amp decoding documentation

Final study report

Investigator Responsibilities

Investigator Responsibilities

16022015 1405Research Methodology DrDeepak Langade

21

Investigator statement

Maintain study documents

Informed consent

Patients wellbeing amp safety

Communication with outside vendors agencies parties

T H A N K Y O U

Questions

Investigator Responsibilities

16022015 1405Research Methodology DrDeepak Langade

21

Investigator statement

Maintain study documents

Informed consent

Patients wellbeing amp safety

Communication with outside vendors agencies parties

T H A N K Y O U

Questions

T H A N K Y O U

Questions