CHAPTER 1. INTRODUCTION

Jun 21st, 2015
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Lecture Field Work Experience Program (KK-PPL), an integrated program carried out in S1 FKIP Jember University is one of the culminating point or estuary program that provides opportunities for students to establish mastery of pedagogical competence, personality,

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Doc.Ref. EMA/540136/2009 ENCePP Checklist for Study Protocols (Revision 2, amended)Adopted by the ENCePP Steering Group on 14/01/2013The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) welcomes innovative designs and new methods of research. This Checklist has been developed by ENCePP to stimulate consideration of important principles when designing and writing a pharmacoepidemiological or pharmacovigilance study protocol. The Checklist is intended to promote the quality of such studies, not their uniformity. The user is also referred to the ENCePP Guide on Methodological Standards in Pharmacoepidemiology which reviews and gives direct electronic access to guidance for research in pharmacoepidemiology and pharmacovigilance.For each question of the Checklist, the investigator should indicate whether or not it has been addressed in the study protocol. If the answer is Yes, the page number(s) of the protocol where this issue has been discussed should be specified. It is possible that some questions do not apply to a particular study (for example in the case of an innovative study design). In this case, the answer N/A (Not Applicable) can be checked and the Comments field included for each section should be used to explain why. The Comments field can also be used to elaborate on a No answer. This Checklist should be included as an Annex by marketing authorisation holders when submitting the protocol of

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