Essential records help evaluate trial conduct, compliance, and reliability of results. Essential records help evaluate trial conduct, compliance, and reliability of results.
Any alteration to essential records must be traceable. Any alteration to essential records must be traceable.
21 CFR 312.62 requires adequate records of investigational drug disposition. 21 CFR 312.62 requires adequate records of investigational drug disposition.
Records of NIH-sponsored studies must generally be maintained for at least: Records of NIH-sponsored studies must generally be maintained for at least:
Progress notes should be brief, factual, dated, and signed or initialed. Progress notes should be brief, factual, dated, and signed or initialed.
Training documents should generally be in place and filed before the trial begins. Training documents should generally be in place and filed before the trial begins.
