MultiMedica Scientific Research


Clinical research and Ethics Committee

Regulatory Bases

The Ethics Committee must assess the applicability of the Judgement of Known on the drug recognized as a medicinal product of no new institution, i. e. the Ethics Committee must determine whether sufficient data have been provided on the clinical safety of the product, such as to be able to exempt the drug from the checks of the Istituto Superiore di Sanità regarding the composition and safety of the product itself according to the Decree of the President of the Republic N 754 of 21 September 1994 and the decrees of the Ministry of Health of 28 July 1994.

RULES for DRAFTING a research project: PROTOCOL

The protocol is a document describing the objective, design, methodology, statistical considerations and organisation of a study. The “Good Clinical Practice” specifies that the protocol usually also provides the basic information and rationale of a Clinical Study, which can also be contained in other documents referred to in the protocol. In the Good Clinical Practice Guidelines, the term protocol means both the protocol and its amendments, meaning “a written description of one or more modifications made to a protocol or a formal clarification of the protocol”.

The protocol must be prepared in the following standard manner:

  • Name of the institution where the research project will take place
  • Title of the protocol
  • Date of submission of the protocol
  • Name and address of sponsor
  • Name, title and address of the responsible researcher (s)
  • Name, qualifications and address of participants
  • Name and address of the Data Processing Center Manager
  • Name and address of the person in charge of the Statistical Analysis Centre
  • Index
  • Summary
  • Introduction and Rational
  • Objectives of the study
  • Sample size
  • Selection of /patients
  • Diagnostic procedures
  • Stratification
  • Randomisation
  • Trapeutic modalities
  • Follow-up
  • Assessment of therapeutic response
  • Pharmacovigilance
  • Clinical monitoring
  • Statistical considerations
  • Documents and access to documents
  • Quality control and quality assurance
  • Eticity
  • Data management
  • Policy for publication
  • Bibliography
  • Appendices: Sample of the data collection card and others
  • Appendices (other if necessary)

The identification number of the protocol is assigned by the Secretariat after approval by the Ethics Committee.