Working After 1.64 Page

Working "after" or in accordance with 1.64 and its associated sections in R3 requires a shift toward and risk-based management .

: Version R3 introduces more flexibility for using digital tools. Working after these updates means clinical staff must be proficient in decentralized trial technologies and electronic data capture (EDC) systems, as the guideline now better supports their use. Impact on Clinical Professionals

The International Council for Harmonisation (ICH) recently updated its Good Clinical Practice (GCP) guidelines to version R3. Section 1.64 defines the , focusing on any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or make important trial-related decisions. Key Principles for Working Under R3 Standards Working after 1.64

: Following 1.64 ensures that the work performed at a local site is recognized and accepted by regulatory authorities worldwide, such as the US FDA or EMA.

: Every person working as a sub-investigator must be explicitly designated. This ensures clear accountability for medical decisions and data integrity. Working "after" or in accordance with 1

: Despite the focus on flexibility, there is a continued emphasis on maintaining reliable, trustworthy data. Workers must ensure that all sub-investigator qualifications and delegated tasks are accurately recorded in the Delegation of Authority Log . GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3) - ICH

: The principal investigator (PI) maintains ultimate responsibility. Working under 1.64 requires documented evidence that the PI is supervising sub-investigators, particularly when they are performing tasks like participant screening or safety assessments. : Every person working as a sub-investigator must

: The update aims to make trial processes more efficient. For workers, this often translates to streamlined documentation and a focus on "quality by design" rather than just checking boxes.

Barbara Landsberg

Sales and Marketing Director SPECTRONICS BOccThy, MBA Barbara is an Occupational Therapist who joined the Spectronics team 14 years ago. Prior to that time, she spent 17 years in occupational therapy positions working with adults and children with a variety of physical disabilities and learning difficulties. She also held the position of Coordinator of the assistive technology service of the Independent Living Centre of Queensland for three years before moving to Spectronics. On completion of her Masters of Business Administration (MBA) in 2010, she assumed the role of Sales and Marketing Director at the company and, among other roles, oversees running of the exciting and innovative Inclusive Learning Technologies Conference hosted every two years by Spectronics. Barbara has a strong interest in the opportunities for students with disabilities or learning difficulties made possible through technology. She is also a passionate advocate of the use of social media tools to promote the power of inclusive learning technologies to enable independent achievement for all – whatever form that achievement might take.

Working After 1.64 Page

Barbara Landsberg

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