Upcm Rido TRB f012 v.5
Upcm Rido TRB f012 v.5
Upcm Rido TRB f012 v.5
COLLEGE OF MEDICINE
UNIVERSITY OF THE PHILIPPINES MANILA
#547 Pedro Gil Street, Ermita, 1000 Manila
Telefax: 522-26-84, Mobile No. 09052266490
E-mail: rido@post.upm.edu.ph website: www.rido.com.ph
STUDY CODE:
TITLE:
Date sent to Reviewer :
Latest date the completed form must be returned to RIDO secretariat :
Instruction to Technical Reviewer:
Each review needs to be explicit and comprehensive. For each section of the protocol, the reviewer should ask the
question: Have they done it correctly?. Please enter, in the right hand column;
Y (yes),
N (no),
? (not sure),
R (for referral to expert),
or NA (not applicable)
This provides guidance for the areas we would like you to comment on. Depending on your area of expertise it is to
be used as a guide only. We do not expect you to comment on every question but would be grateful if you can
complete as many boxes as possible.
Title
Is the title a good reflection of the study?
Reviewers comment:
Background
a.Does the background support the need for the study by providing sufficient
information about the underlying clinical problem?
b. Are the uncertainties in the clinical problem clearly stated?
c. Does the background address issues that are particularly important for its
target readers?
Reviewers comment:
Objectives
a. Was the main objective of the study specified clearly?
b. Does the study address an important scientific issue?
c. Will these be meaningful to patients and healthcare providers?
Reviewers comment:
Methodology
Study Design (please see appendix for details)
a. Is the study design clearly stated?
b. Is the study design appropriate to the objective of the study?
Reviewers comment:
Sample Population
a. Is the selection of study sample clearly stated and appropriate?
b. Are the inclusion / exclusion criteria clearly stated and appropriate?
c. Is the subject recruitment process described and consistent with the study
design?
d. Is the sample size clearly stated and justified?
Reviewers comment:
Study Procedures
a. Are the study interventions and comparators clearly described?
b. Is the choice of interventions and comparators appropriate?
Reviewers comment:
Outcomes:
a. Is one (or a small number of) primary outcome(s) identified?
b. Are all other important (beneficial and harmful) outcomes considered?
c. Is the assessment of the outcomes clearly described or defined?
Reviewers comment:
V. Data Analysis
a. Is the method of data recording, analysis and reporting clearly described?
b. Are the statistical techniques to be used appropriate?
Reviewers comment:
Use additional sheets if necessary. Attached to this form are guide questions which may help the review.
) FOR MODIFICATION (Instruction to PI: Accomplish UPCM RIDO Form TRB F013 and submit back to
TRB Reviewer)
) DISAPPROVED
_____________________________________
Signature over printed name of TRB Reviewer
____________________________
Date
( ) APPROVED
_____________________________________
Signature over printed name of TRB Reviewer
____________________________
Date
ENDORSED BY:
___________________________________
__________________________________
RUZANNE M. CARO, MD
Department of :
Chief, RIDO
Date:
Date:
Study Code: