2016年10月5日 · The EMA reflection paper ALCOACCEA principles applies to paper as well as electronic data. "A number of attributes are considered of universal importance to source data and the records that hold those data". These attributes would not be universal if …

2021年5月26日 · MHRA (like all other regulators) expect high quality data that conforms to ALCOACCEA. Of vital importance is attribution of all data and documentation. Best to read all of ICH E6 R2.

2015年4月28日 · ICH E6 (R1) has got lots of details about how source documents are to be amended in compliance with GCP. The EMA reflection papers gives the expectation of EU GCP Inspectors for both paper & electronic source including the ALCOACCEA standards. The MHRA GCP Guide (2012) has a wealth information to help you.

2012年11月27日 · EU Guidance Volume 10 Chapter 5 is very useful about this. Also the EMA GCP Inspectors website Q & As. Also the EMA GCP Inspectors reflection paper on electronic source which contained guidance on paper source as well. Here the inspectors propose the ALCOACCEA quality standard for source.

2015年2月13日 · The EMA (Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials 09June2010 effective 01Aug2010) states that the quality aspects of source documents (ALCOACCEA) are considered universal regardless of whether they are paper or electronic.

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