Republic of the Philippines

Department of Health
ZAMBOANGA CITY MEDICAL CENTER
Dr. D. Evangelista St., Sta. Catalina, Zamboanga City, 7000

PROTOCOL EVALUATION FORM

ERC Protocol No. Date: 2/20/19

Protocol Title: Thai-Lepto-On-Admission Probability (Thai-Lepto) Score as an Early Tool

for the Diagnosis of Leptospirosis in Zamboanga City Medical Center

Principal Ann Marie A. Abujen, MD, MPH

Investigators
Department Internal Medicine Contact no. 09178938579
Email
Co-investigator(s) Afdal B. Kunting, MD, MPH Contact no.
Email
Total No. of 40 No. of Study Sites
participants
Sponsor None Contact No.
Email
Duration of the 1 year Status ERB and TRB review
Study
Reviewers

Type of Study  Intervention  epidemiology  Observational study

 Document review  individual based  Genetic
 Social Survey  Others, specify
Analytical
Review Status
 Full Board
 Expedited

Description of the study in brief: Mark whatever applies to the study

 Randomized  Drug  Use of Genetic Materials
 Double blind  Medical Device  Multicentre study
 Single blind  Vaccine  Global protocol
 Open label  Diagnostics  Sponsor initiated
 Observational  Questionnaire  Investigator initiated

ZCMC-F-PET-RES-07 Rev. 1 Effectivity Date: March 19, 2018 Page 1 of 3

A. PROTOCOL DOCUMENT REVIEW

1. Objectives of the study  unclear What should be improved?

 clear
2. Need for human Participants  No Comment :
 yes
3. Methodology  unclear What should be improved?
 clear
4. Background Information and data  Insufficient Comment:
 Sufficient

5. Risks and Benefits Assessment  Unacceptable Comment

 Acceptable
6. Inclusion Criteria  inappropriate Comment
 Appropriate
7. Exclusion criteria  Inappropriate Comment:
 Appropriate
8. Withdrawal Criteria  Inappropriate Comment:
 Appropriate
9. Involvement of vulnerable Participants  Inappropriate Comment:
 Appropriate
10. Voluntary, Non-Coercive Recruitment of  No Comment:
participants
 Yes
11. Sufficient number of participants  No Comment:
 Yes
12. Control Arms (placebo if any)  No Comment:
 Yes
13. Are the qualifications and experience of the  No Comment:
participating investigators appropriate?
 Yes
14.Disclosure or declaration of potential conflicts  No
of interest
 Yes
15.Facilities and infrastructure of participating  No
sites
 Yes
16. Community consultation  No
 Yes
17. Involvement of local researchers and  No
communities in the protocol preparation and
implementation
 Yes

ZCMC-F-PET-RES-07 Rev. 1 Effectivity Date: March 19, 2018 Page 2 of 3

18. Contribution to local capacity building No
 Yes
19.Benefits to local communities No
 Yes
20.Sharing of study results No
 Yes
21.Are blood/tissue samples sent abroad No
 Yes
B. RECOMMENDATION

DECISION  Except from Review  Minor revisions required

 Approved  Disapproved
 Major revision/resubmission
Comments
(Identify Items for
revision)

Receiver’s name Date

Signature

ZCMC-F-PET-RES-07 Rev. 1 Effectivity Date: March 19, 2018 Page 3 of 3