Come scrivere un protocollo di ricerca clinica

A volte tra i tanti requirements richiesti per un CRA o per un Project Manager (specie per le piccole CRO) è quello di saper scrivere un protocollo di ricerca clinica.

Grosso modo puoi seguire questo schema:

Study Summary

1 Introduction

1.1 Background

1.2 Investigational Agent

1.3 Preclinical Data

1.4 Clinical Data to Date

1.5 Dose Rationale and Risk/Benefits

2 Study Objectives

3 Study Design

3.1 General Design

3.2 Primary Study Endpoints

3.3 Secondary Study Endpoints

3.4 Primary Safety Endpoints

4 Subject Selection and Withdrawal

4.1 Inclusion Criteria

4.2 Exclusion Criteria

4.3 Subject Recruitment and Screening

4.4 Early Withdrawal of Subjects

4.4.1 When and How to Withdraw Subjects

4.4.2 Data Collection and Follow-up for Withdrawn Subjects

5 Study Drug

5.1 Description

5.2 Treatment RegimeN

5.3 Method for Assigning Subjects to Treatment Groups

5.4 Preparation and Administration of Study Drug

5.5 Subject Compliance Monitoring

5.6 Prior and Concomitant Therapy

5.7 Packaging

5.8 Blinding of Study Drug

5.9 Receiving, Storage, Dispensing and Return

5.9.1 Receipt of Drug Supplies

5.9.2 Storage

5.9.3 Dispensing of Study Drug

5.9.4 Return or Destruction of Study Drug

6 Study Procedures

6.1 Screening Visit

6.2 Post Randomization Treatment

6.3 End of Medication Evaluation

6.4 Follow-Up Evaluation

7 Statistical Plan

7.1 Sample Size Determination

7.2 Statistical Methods

7.3 Subject Population(s) for Analysis

7.4 Data Management

8 Safety and Adverse Events

8.1 Definitions

8.2 Recording of Adverse EventS

8.3 Reporting of Serious Adverse Events

8.3.1 Study Sponsor Notification by Investigator

8.3.2 IRB/EC Notification by Investigator

8.3.3 FDA Notification by Sponsor

8.4 Unblinding Procedures

8.5 Medical Monitoring

8.6 Protection of Subjects

9 Data Handling and Record Keeping

9.1 Confidentiality

9.2 Source Documents

9.3 Case Report Forms

9.4 Records Retention

10 Study Monitoring, Auditing, and Inspecting

10.1 Study Monitoring Plan

10.2 Auditing and Inspecting

11 Ethical Considerations

11.1 Consent Procedures

12 Study Finances

12.1 Funding Source

12.2 Conflict of Interest

12.3 Subject Stipends or Payments

13 Publication Plan

14 References

15 Attachments

Se vuoi avere un'idea concreta su come è fatto un protocollo di ricerca clinico puoi visionarne uno qui.

Ciao e alla prossima,
CRAlife