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Diosdado Macapagal Government Center, Maimpis, City of San Fernando, Pampanga

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REQUIRED DOCUMENTS FOR CLHRDC-ETHICS COMMITTEE REVIEW OF AN INITIAL PROTOCOL SUBMISSION The principal investigator shall be required to submit one hard copy and electronic copy of the following applicable documents to the CLHRDC Secretariat before ERC review of the research proposal: 1. Ethics Review Committees Standard Application Form for Ethical Evaluation of Proposed Study (see Appendix B- Application form) 2. Results of technical/ethical review from other ERCs (if applicable) 3. Research protocol (see Appendix C- CLHRDC-EC Research Protocol Format) that includes: a. Title of the proposal b. Significance of the study c. Literature review d. Objectives of the study e. Methodology and procedures f. Description of the study population g. Exclusion/Inclusion criteria h. Ethical considerations that should state what relevant international and national guidelines will be used as reference in the study and include ethical issues h.1. Anticipated risks (how these will be minimized) and why they are outweighed by potential benefit h.2. Protection of confidentiality of data and privacy of the research participants

CLHRDC-EC Rev 1 05/04/12

h.3. Vulnerability of the research participants h.4. management of adverse effects h.5. How informed consent will be obtained i. Data Analysis j. Safety Information j.1. Safety precaution j.2. Contact person and telephone number in case of emergency situation 4. Written Information for the participants of the study (see Appendix D1- Template for Patient Information Form) 5. Informed Consent/assent documents- These must be both in English and in language appropriate to the level of understanding of the research participant. (see Appendix D1-sample template of statement to be written in an ICF) 6. Study Tools (questionnaires, case report form, posters/advertisements for recruitment, etc) 7. Study drug/medical device information like investigator brochures/ published literature / medical device manufacturers design, if relevant 8. Curriculum vitae of principal investigators and co-investigators which will also include relevant training and proof of their GCP training (in case of a clinical drug trial) 9. Information regarding funding, sponsors and institutional affiliations 10. Contracts and approval of relevant offices (memorandum of Agreement (MOA) if study is collaborative in nature; Materials Transfer Agreement (MTA), Intellectual Property approval, Investigational Device Exemption (IDE), when relevant 11. Study/Protocol Budget

CLHRDC-EC Rev 1 05/04/12