Note to File/Memo to File: Note to file (NTF) is used when we deviate from our SOPs or procedure of conduct in clinical trials. It gives an explanation for the observations during the monitoring and provides clarification on the matters of conduct of the study. Hence avoiding the remarks of audit/monitoring. Complete and accurate Note to File (NTF), documented in the Investigator File, is essential documents because they record unusual incidents that are likely to raise questions in future. We at Healing Hands Clinical Research Services provide GCP trained Study coordinator who can run trail activities in well organized way. This reduces discrepancies in the conduct of clinical study and the extensive use of NTF. A common misuse of NTF is generating one, when enough documentation in source documents are needed. Data are entered for several subjects together in the NTF rather than writing it in the source documents and later can be explained to Monitor. Excessive use of NTF should be avoided as it fails to adequately address some of the major discrepancies in the Clinical Study. At Healing Hands Clinical Research Services we understand that the primary concern is to implement a corrective action rather than using NTF as a convenient means to document issues. Good performance is recorded with good recordkeeping practices instead of writing NTFs. We have developed SOPs for site and quality system to understand the complexity of the protocol before study initiation such that issues could be detected early and quality assurance measures could be taken.
Posted on: Sat, 08 Mar 2014 06:53:09 +0000
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