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Thread: Guidelines about the ALCOACCEA principles on paper documentation

  1. #1
    Forum Member
    Join Date
    Oct 2016

    Guidelines about the ALCOACCEA principles on paper documentation

    I am looking for an EMA guideline, RP, ... that describes the use of the ALCOACCEA principles in paper documentation.
    What i found is this reflection paper which is related to eletronic data.
    I would appreciate any orientation on that,
    Kind regards,

  2. #2
    Forum Member
    Join Date
    Nov 2011
    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 they did not apply to paper.
    The EMA GCP Inspectors Q & A website says :- "all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data should be accurate, legible, contemporaneous, original, attributable, complete and consistent. Source data is documented in source documents which may be both electronic and on paper".

    Also the MHRA has a draft on GXP data integrity that includes this.

    WHO has a very good document where they talk at length about ALCOACCEA which they refer to as ALCO plus. WHO - Annex 5: guidance on good data and record management practices

    CDISC (Clinical Data Interchange Standards Consortium) is a good place to look

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