Good Documentation Practice

SOP #: PM-3

Next Review Date: 05/2016

Version #: 1.0

Review Interval Period: Biennial

Approved Version #: 05/14


Purpose: To establish guidelines for clinical research documentation for various time points during a subject’s participation in a clinical research protocol. All licensed practitioners are to document their subject encounters in the NIH medical record (CRIS). Medical record documentation is part of good documentation practices; other aspects include maintaining participant research records and a protocol specific regulatory file (see SOP REG-12). Note: Clinical Data Managers under contract to the CCR are not allowed to document in the medical record/CRIS.
General Principles

NOTE: Free text progress notes do not have this option. Labeling a note is a feature for structured progress notes.


Informed Consent Process

NOTE: Once eligibility is confirmed and informed consent is obtained, remember to register the subject with the Central Registration Office per CCR SOP AD-4.

Past Medical History/Prior Therapies

Concomitant Medications/Measures and Baseline Symptoms

NOTE: This information is important due to off-labeled use of medications. Some medications are given for indications not approved by the FDA. Staff should not assume that the subject is taking the medication for the condition listed in the package insert.

NOTE: For treatment trials, baseline signs and symptoms are those that are present when the patient starts treatment (e.g., Cycle 1 Day 1 pre-dosing). These are not signs or symptoms that occurred and resolved between the time screening studies/exams/procedures are done and Day

Scheduled Study Visit

NOTE:  This may be done through evidence of lab results or other procedures documented in CRIS or via an outside progress note/labs/tests.

NOTE: For protocol-specific activities that are carried out by the CC staff (e.g., PK or serial blood draws), ensure that these activities have been documented in CRIS.

NOTE: For subject completed forms (e.g., surveys and diaries), a CRIS education note(s) is required and needs to include that the participant was given instructions and understands how to use the forms.

Study Drug Administration

NOTE: Ensuring that subjects are taking and storing their study drug appropriately is an ongoing process. All documentation related to teaching/reinforcement needs to be documented in CRIS.

Adverse Events

For all AEs, the following will be documented in one or a series of progress notes in CRIS: 

NOTE: May also need to document the time of the AE (e.g., allergic drug reaction, transfusion reactions).

NOTE: Please make sure for subjective AEs that there is a description and not just a grade level.

NOTE: This includes interruption or discontinuation of the study intervention(s).

NOTE: An adverse event should be followed until it has resolved or, for an adverse event that might not ever resolve (e.g., neuropathy, alopecia), until it has stabilized. Include documentation of the resolved or stabilized date.

 Adverse Events Attributes

Dichotomized Approach

5 Option Approach

Attribution Definition Attribution Definition
Related Reasonable causal relationship between the AE and the intervention/research. Definite AE clearly related to the intervention/research.
Probable Likely related to the intervention/research.
Possible May be related to the intervention/research.
Unrelated No reasonable causal relationship between the AE and the intervention/research. Unlikely Doubtfully related to the intervention/research.
Unrelated Clearly not related to the intervention/research.

Unscheduled Visits

Off Treatment

NOTE: This may be the same as the date of a scan or the last dose of drug, but not always.This is not the same date as holding the research intervention to wait for resolving of adverse events.


NOTE: Lost to follow up subjects need to be documented in CRIS along with information on what was done to attempt to contact the individual.  If the investigator decides to take them off study, this information will need to be documented in CRIS.

Off study

NOTE: Once a participant is taken off study, remember to inform the Central Registration Office per CCR SOP AD-7.

Telephone Calls

E-mail Correspondence Within NIH

E-mail Correspondence with Provider/Patient

General:  A patient or their legally authorized representative (LAR) may request to communicate with NIH health care providers or other authorized NIH staff via secure encrypted e-mail. Secure e-mail communication must be accomplished utilizing the Clinical Center’s Medical Secure E-mail Service ( E-mail communication with patients can begin only after the authorized NIH staff initiates the process. The NIH reserves the right to deny a patient’s request to communicate with him/her via secure e-mail or to terminate a patient’s access to secure e-mail at any time. Email sent and received through the secure encrypted process must not be stored on individual computers, servers, and/or databases.

NOTE: If the patient’s request to communicate via secure email is granted by the MRD, the patient will be required every time they use the system to acknowledge receipt of the Important Information about Provider/Patient Email brochure describing the risks of engaging in secure email communications with his/her providers and/or authorized NIH staff prior to engaging in secure email.