“ALCOA”: ELEMENTS OF GOOD DOCUMENTATION

1 Research Compliance and Integrity Tel: 858 822-4939 / Email: X:\ORA\RESEARCH COMPLIANCE\EDUCATION\Fact Sheets\ALCOA Standards ALCOA ELEMENTS of Good DOCUMENTATION Issued: March 2021 ALCOA : ELEMENTS OF GOOD DOCUMENTATION Thorough DOCUMENTATION is vital to ensure compliance with federal and state laws as well as institutional policies related to the conduct of research. The Food and Drug Administration (FDA) first introduced the ALCOA concept, Attributable, Legible, Contemporaneous, Original, and Accurate, as the fundamental principles of data quality that research DOCUMENTATION must meet. The International Council for Harmonization (ICH) E6(R2) addendum for Good Clinical Practices further added the Complete principle to ALCOA. Thorough DOCUMENTATION in research allows for the reconstruction of the research as it happened.

2 All ELEMENTS of the acronym ALCOA apply to both paper and electronic source data, and the records that hold that data. The degree to which the data fulfills the data quality criteria establishes the acceptability of the data. The table below describes all ELEMENTS of ALCOA-C . Attributable The raw data is traceable to authorized person recording the data When documenting research data on paper, every element needs to be traced back to the person recording the data. The data should be traced by a signature or initials to the individual who observed or recorded the data and the date it was observed or recorded. If the data is edited on the source record, it needs to be initialed, dated, and a reason for the change should be included so that it can be traceable to the individual who made the change, when the change was made, and why the change was made.

3 Similarly, if data is entered into the source record at a later date, initial and date with the current date and note late entry. In an Electronic Data Capture (EDC) system is utilized, an audit trail makes it easy to identify when a record was created, edited, signed, or viewed as well as who performed an action on the record and the reason for the action. Legible The raw data is easy to read Everything that is written must be legible and signatures should be identifiable. Handwriting must be clear to reduce the possibility of transcription errors and should be in blue or black ink. Do not obscure the original entry: Do not use white-out, write over entries, or paste any labels over the raw data. Do not black-out or redact entries except when it is necessary to comply with HIPAA. In an EDC system, all data are in a readable and identifiable format.

4 Contemporaneous The raw data is recorded at the time of observation The data should be documented at the time the event occurs. Do not Research Compliance and Integrity Tel: 858 822-4939 / Email: X:\ORA\RESEARCH COMPLIANCE\EDUCATION\Fact Sheets\ALCOA Standards ALCOA ELEMENTS of Good DOCUMENTATION Issued: March 2021 pre-date or back date. If observation cannot be entered when made, chronology should be recorded and documented as late entry. Acceptable amount of delay should be defined and justified. If a signature and date are required, the date must be completed by the same person signing the form. If an EDC system is utilized, built-in controls such as automatic time and data stamps and electronic signatures reduce the possibility for transcription errors. Original The data is the firsthand observation and not a copy Source document is when the pen hits the paper for the first time.

5 Original study records should always stay be retained by the study site. If data is directly entered into the EDC system, a monitoring/auditing/inspecting body (Monitor) may request documents to verify the direct entry of source data ELEMENTS into the EDC system. For example, if the Electronic Medical Record (EMR) is used as a source, the Monitor may request access to the EMR or require that you print the applicable information from EMR and file with the subject s research record. Accurate The data is unaltered and correct recording of the observation The source record must completely reflect the true observation(s). This means an honest, accurate, and thorough representation of facts describing the conduct of the study. When source documents are incomplete, inconsistent, or incorrect, a Note to File or a Progress Note must be attached to the record clarifying the issue.

6 If a correction needs to be made, it must be done in a compliant manner ( , line through the original entry leaving the original entry readable, initial and date the line through and write in the correct entry). If an EDC system is utilized, audit trails can prevent data from being altered. Automatic edit checks can be alerted when data points are missing or out-of -range data is entered. (Complete) The data includes all data from the study All data must be retained from the creation of the DOCUMENTATION . Deletion or removal of data must not take place. In an EDC system is utilized, each record features a dedicated history with all actions taken since the creation. A trackable audit trail proves that nothing has been deleted or lost. Research Compliance and Integrity Tel: 858 822-4939 / Email: X:\ORA\RESEARCH COMPLIANCE\EDUCATION\Fact Sheets\ALCOA Standards ALCOA ELEMENTS of Good DOCUMENTATION Issued: March 2021 Training and Resources Thorough DOCUMENTATION is pivotal to Good Clinical Practices (GCP).

7 GCP is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials or research studies. Training in GCP can be completed through a class or course, academic training program, or certification from a recognized clinical research professional organization. Below are some options for GCP training that are available without charge. UCSD Collaborative Institutional Training Initiative (CITI) Program National Institute of Allergy and Infectious Diseases (NIAID) National Institute on Drug Abuse (NIDA) NIH Office of Behavioral and Social Sciences Research (OBSSR) Please see the Research Compliance and Integrity (RCI) Office Good Clinical Practice page for general information on GCP training and the Good Clinical Practice Frequently Asked Questions (FAQs) page. For additional information or assistance, please contact RCI at or 822-4939.

8 References 21 Code of Federal Regulations (CFR) (c) and (e) FDA guidance: E6(R2) Good Clinical Practice FDA guidance: Data Integrity and Compliance with Drug Good Manufacturing Practice (CGMP) FDA guidance: Electronic Source Data in Clinical Investigations