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Recent experience in these regions suggests that, absent a model of institutional harmonization and a road map for policy convergence, Latin American economies would benefit from following internally consistent macroeconomic policies possibly in the context of a rules-based framework and from adopting widely accepted standards of best practice.
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For initiatives that involve multi-institutional collaboration, there are assorted data harmonization processes in place.
The study was completed in compliance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice Guidelines; institutional review boards reviewed and approved the protocol for each study site; and all patients provided written, informed consent before participation in the trial (11, 12).
The present study was approved by the institutional review board at two institutions and was conducted in accordance with the International Conference on Harmonization Guidelines for Good Clinical Practice.
This study is to be conducted according to US and international standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), applicable government regulations and Institutional research policies and procedures.
The study was conducted in accordance with the protocol approved by the institutional review boards of the participating institutions, and with the Harmonized Tripartite Guideline of the International Conference on Harmonization for Good Clinical Practice.
First, implementing cross-country, multi-institutional research projects takes time because of the harmonization required with respect to both methodology and timing.
Both studies were conducted in accordance with ethical principles based on the Declaration of Helsinki, good clinical practice, and International Conference on Harmonization guidelines, and were approved by a local institutional review board.
Regularly conducted structured training, communication about the review processes, public demonstration of leadership support for research ethics activities, budgetary allocation to ensure sustainability, and greater harmonization of research ethics processes with the broader institutional activities are some ways in which "institutionalization" of research ethics system can be deepened [ 26, 27].
The protocol was approved by each site's institutional review board and was conducted according to the International Conference on Harmonization Guidelines for Good Clinical Practice and the Declaration of Helsinki.
The study protocols were approved by a central institutional review board and were conducted in accordance with the International Conference on Harmonization Guidelines for Good Clinical Practice.
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