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 Summary1 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4.4.2 Data Collection and Follow-up for Withdrawn Subjects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
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