Your Easy Guide to Clinical Studies

Depending on their roles and responsibilities study team members can provide important feedback on the feasibility of a study.

 

Based on the complexity of the study, feedback can inlcude information on:

• The study design: such as resources, definition of work flow and processes, required time investment and expertise, access to study participants
• Required Infrastructure: such as special equipment, access to patient rooms, labs, access to storage space for biological material, study documents, and investigational product (e.g. IMP / IMD)

• Required documentation: such as study documentation (TMF/ISF), applicable SOPs /Wis, logs, safety reporting, communication with SP-INV and study partners (e.g. study monitoring / data management)

• Study Experience: such as data entry, the coordiination of the study team, participant  and lessons learned from previous studies

 

Feedback should be collected from all parties involved, SP-INV team and Site-INV team. 

The SP-INV makes final decision regarding study feasibility and whether to implement a study as planned.

As a member of the study team:

• Read the study protocol, the Investigational Brochure (IB) (if applicalbe), and the questions listed in the feasibility questionnaire
• In order to support the quality of the study, maintain a Quality by Design (QbyD) approach during the assessment 
• Assist in the identification of the study`s Critical to Quality (CtoQ) factors, including the identification of risks threatening their integrity (e.g. participant right and safety, data quality)
• Suggest risk control-measures protecting CtoQ integrity
• Assess and provide feedback on the study`s feasibility by using a problem-solving approach

 

As a Site-INV:

• Request support from study team members based on individual expertise.
• Include risks for an overall evaluation of study feasibility. Include risk experiences under lessons learned from previous studies
• Forward the feasibility assessment to the SP-INV within the deadline

 

In the event of study implementation, implement a risk-based Quality Management System at the site to ensure the ongoing quality of the study.

References

ICH GCP E6(R3) – see in particular guideline

• 2.3 Responsibilities
• 3.10 Quality management

ICH E8(R1) – see in particular

• 3.1 Quality by Design of clinical studies
• 3.2 Critical to Quality Factors

ISO 31000 (access liable to costs) – see in particular section

• Risk management: Principles and guidelines