4) Procedures:

a. If the study involves only the analysis of existing data or samples:

q Describe the origin of data and whether they are available to the public or not.

q Indicate whether the principal researcher and other researchers were involved in the original data collection.

q Describe if the original database includes identification information and if the format of the database to be used in the new study includes identifiers or not.

q Provide a data analysis

b.If the study involves direct or indirect contact with subjects, provide the following information:

q Design of the study and methods.

q Study procedures, including the sequence and timing.

q Number of contacts or visits required from participants and duration of each.

q Expected duration of the study.

q Plan of data analysis and description of variables from which they are derived.

q If human biological specimens (blood, urine, saliva, etc.) will be collected, provide details about the collection, volume (ml) or number, use, storage, identification and elimination.

q If there will be a control group, explain and justify its use. Describe how subjects will be analyzed for eligibility and randomized to intervention and control group.

q Explain and justify if there will be a cover-up (i.e. simple or double-blind).

q Explain and justify whether any of the participants will not receive routine care or if their current therapy will be

q Explain and justify the use of placebo or untreated group.

q Provide definition of treatment failure and criteria for early removal of study participants.

q Describe what happens to participants receiving therapy at the end of the study, or if participation ends

q Describe the referral procedures for participants to other centers outside the Studio, if necessary.

q If interventions are evaluated, prepare a randomized study design, and / or if a clinical trial, provide the calculations for the projected sample size.

q Describe any plans for the communication of results of participants. For medical studies, describe how the results will be.

5.Information security and protection of the subject confidentiality.

a. Specify who will have access to personal data of participants, including medical records and biological samples.

b. Describe the measures that will be carried out to ensure confidentiality and security of personal information of participants in research.

c. If identifiers are to be used, describe the plans for eliminating them, identifying where and how.

d. Describe any existing plan that exists for the destruction of data. Indicating, when and how it will be.

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