Frequent Questions

What type of sponsor-testing facility communication is considered to be raw data which must be archived at the end of the study?

All records of sponsor-testing facility communication which occur as part of the activities of a study are considered to be raw data, as defined at 40 CFR 160.3. This includes memoranda, letters, and records of telephone conversations which occur during the course of the study. Communication conducted prior to the study (i.e., before the protocol is signed) or following the completion of the study (i.e., after the report is signed) would not normally be considered to be raw data. Note that certain records not specific to a particular study which are generated when the study is not in progress still need to be retained to prove that study's compliance with GLPS. Examples include records of a sponsor's notifying a facility of the need to comply with GLPS as required at 40 CFR 160.10, and records of facility documents such as standard operating procedures.
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