Easily a Week of GDocP Errors

SMBC Comics, http://smbc-comics.com/comic/date-2

Ah, the New Year. A time of trying to remember how to write the correct date and mostly failing. A time where I practice my capability to make simple corrections on forms still completed by hand.

ISO 8061 Adoption in Pharma

How widespread is adoption of ISO 8601, the standard for date and time formats? Is your company aligned?

I see ISO 8601 widely used in scientific fields, software development, and more and more international correspondence. Yet, I think its fair to say the adoption in pharma has been lacking. So I am really curious, has your organization fully or partially adopted it? If so, how did it go?

Date Format

The basic principle of ISO 8601 for dates is to represent them in a descending order of significance:

Complete date: YYYY-MM-DD (extended format) or YYYYMMDD (basic format)
Example: 2022-09-27 or 20220927
Year and month: YYYY-MM
Example: 2022-09
Year only: YYYY
Example: 2022

Time Format

ISO 8601 defines the following time format:

Basic format: Thhmmss
Extended format: Thh:mm:ss

Where:

T is the time designator
hh represents hours (00-24)
mm represents minutes (00-59)
ss represents seconds (00-60, where 60 is used for leap seconds)

Example: T134730 or T13:47:30 represents 1:47:30 PM

Combined Date and Time

ISO 8601 allows combining date and time representations:

YYYY-MM-DDThh:mm:ss or YYYYMMDDThhmmss

Example: 2022-09-26T07:58:30 represents September 26, 2022, at 7:58:30 AM

Time Zone Designators

The standard also specifies how to represent time zones:

Z: Represents UTC (Coordinated Universal Time)
±hh:mm or ±hhmm: Represents the offset from UTC

Example: 2022-09-07T15:50+00:00 or 2022-09-07T15:50Z represents 3:50 PM UTC on September 7, 2022.

Key Features

The standard uses the Gregorian calendar.
It employs a 24-hour clock system.
All elements are represented by a fixed number of digits, zero-padded if necessary.
The standard allows for reduced precision by omitting certain elements.
It can represent dates, times, time intervals, and recurring time intervals

Government and Official Use

Many countries have officially adopted ISO 8601 as their recommended or mandated date format for government and official use. For example:

The UK government has mandated the use of ISO 8601 for IT systems, APIs, and machine-to-machine communication.
Canada’s government and Standards Council officially recommend ISO 8601 for all-numeric dates.
Australia recommends ISO 8601 as the short date format for government publications.

The European Union has adopted ISO 8601 as the European Standard EN 28601, making it valid in all EU countries.

Has anyone seen Health Canada or an EMA (and/or national competent authority) push back at a time/date not in ISO 8061 format? I think there has been a lot of push back in health care around adoption, for example the NHS in the UK uses 01-JAN-2017 for medicine labels even though the UK has adopted ISO 8061.

I find it fascinating that the eCTD specification does not mandate a specific date format for metadata or content within submissions, allowing flexibility for regional requirements. Yet we have seen many health authorities that have implemented eCTD do recommend or require the use of ISO 8601 date formats in certain contexts:

The US FDA guidance on eCTD recommends using ISO 8601 format (YYYY-MM-DD) for dates in the submission.
The EU guidance on eCTD also recommends ISO 8601 format for dates in certain metadata fields.

The eCTD XML backbone uses the W3C XML Schema date and dateTime datatypes, which are based on ISO 8601 formats. While not explicitly requiring ISO 8601, the eCTD specification does emphasize the importance of consistent and unambiguous date representations, which aligns with the goals of ISO 8601. It really makes me wonder when this decision will start rippling through other parts of the industry.

I’d love your thoughts.

The Difference Between Education and Training and Impact on Procedure

When we solve problems in the wrong way, we end up creating bigger problems. One of the biggest of these stems from the differences between education and training and how we try to address education deficiencies (real or perceived) in the procedure.

Training: The primary goal of training is to develop specific skills and behaviors that improve performance and productivity in a particular job or task. It is practical and hands-on, focusing on applying knowledge to perform specific tasks effectively. For example, training might involve learning how to use a particular software or operate machinery .
Education: Education aims to provide a broader understanding of concepts, theories, and principles. It is more about acquiring knowledge and developing critical thinking, reasoning, and judgment. Education prepares individuals for future roles and helps them understand the broader context of their work.

For example, in writing a procedure on good documentation practices (GDocP), we might include a requirement to show the work on all calculations except simple. Knowledge of the broader principles of mathematics is education, and a simple calculation is a fundamental building block of mathematics. We now have two choices. We can proceduralize a definition and provide examples of simple calculations, or a basic understanding of mathematics is a prerequisite for doing the work, part of the core competencies.

This example may seem minor, but it quickly builds up. Every time we add an item that should be education to a procedure, we increase the difficulty of using and training on the document. Good documentation practices are a great example because we take some basic ALCOA+ concepts and then give possible permutations, many of which rely on education premises.