What is it? Why is it important?

Site Qualification (SQ) indicates whether a potential study site is suitable to participate in a planned study.

SQ checks include, but are not limited to an analysis of:

  • Site-INV`s interest in study participation, with no active participation in competing studies
  • Site experience in conducting similar types of studies
  • Sufficient time to invest in a study
  • Sufficient resources
  • Adequate number of potential study participants
  • Qualified study staff
  • Facilities (e.g. laboratories)
  • Infrastructure (e.g. IT, work-, storage-, freezer space, patient rooms)


  • A SQ check should address all aspects pertaining to the successful conduct of a study.
  • Taking time to assess SQ is an important investment because it avoids problems that potentially could have been prevented.
  • Managing problems during study implementation and conduct will delay and most likely require additional resources and funding.


Some aspects may require more detailed investigations. An example would be the handling and storing of biological material:

  • Does the site have access to storage equipment such as freezers at the required temperature (e.g. −80°C)?
  • How are freezer access rights managed?
  • How is freezer temperature monitored?
  • Are there emergency procedures installed in the event of freezer failure?

What do I need to do?

As a SP-INV and depending on how you plan to set up your study, you need to:

  • Define study relevant SQ questions
  • If applicable, add questions addressing issues from your past experiences or lessons learned from previous similar studies
  • Leave space for the Site-INV to include questions, comments, and suggestions


Writing a SQ or feasibility questionnaire can be quite challenging because not all eventualities can be predicted. Some aspects may only become apparent during study conduct.


Explicit questions could be included in a SQ questionnaire , such as, does the site have:

  • Sufficient time and adequate resources?
  • A sufficient number of participants potentially willing to participate in the study?
  • Ability to adhere to required safety reporting procedures (e.g. 24-hour emergency cover)?
  • Appropriate storage facilities for IMP/MD?
  • Appropriate procedures for handling IMP (e.g. storage, processing, and shipment procedures)?
  • A suitable QMS in place (e.g. SOPs, WIs, staff trainings, relevant processes for managing study tasks)?
  • No competing studies to be conducted in parallel which would jeopardize the adequate amount of participants available for the study?


A SQ check is preferably done based on a personal visit to the site. Many study aspects are difficult to check remotely, such as required infrastructure and facilities.

It is always an advantage to establish a personal contact with an on-site study staff member. This makes it easier to evaluate the site, establish a robust communication line, and solve future problems.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic


ICH GCP E6(R2) – see in particular guidelines

  • 5.6 Investigator selection
  • 5.18 Monitoring activities

ISO 14155 Medical Device – see in particular section (access liable to costs)

  • 6.8 Investigation site selection
  • 9.2.4 Monitoring
  • 10.3 Qualification of investigation site
  • CTU – Clinical Trials Unit
  • Site-INV – Site Investigator
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • ISO – International Organisation for Standardisation
  • IT – Information Technology
  • QMS – Quality Management System
  • SQ – Site Qualification
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • WI – Working Instruction
Concept ↦ Monitoring ↦ Monitoring ↦ Site Qualification

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Concept ↦ Monitoring ↦ Monitoring ↦ Site Qualification

Please note: the Easy-GCS tool is currently under construction.