What is it? Why is it important?

In clinical studies Investigational Medicinal Product (IMP) or Medical Devices (MD) are tested for safety and efficacy.

  • An IMP is an active ingredient or a placebo that has been pharmaceutically prepared and is being tested or used as a comparator.
  • MD can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article to be used, alone or in combination. MDs are mainly used for diagnostic and therapeutic purposes.
  • IMP/MD management includes:
    • Manufacturing
    • Transport
    • Storage
    • Labelling
    • Dispensation and use
    • Expiration
    • Destruction

More

Package inserts provide information about the drug and its use, such as:

  • Owner, product name, its chemical and structural formula
  • Required storage conditions and expiration date
  • Efficacy and indication. How the product is supposed to be used and how it works
  • Contraindications where the product should not be used
  • Warnings of potential side effects, adverse reactions, drug abuse and dependence
  • Dosage and administration

Investigator’s brochure (IB): Is a compilation of preclinical and clinical data, including quality data on the IMP/MD relevant to the study. For products that are not already on the market and lack a finalized package inserts, the IB might be the only available information.

Products that may be considered medical devices:

  • Disinfectant substances
  • Aids for persons with disabilities
  • Devices incorporating animal and/or human tissues
  • Devices for in vitro fertilization or assisted reproduction technologies

What do I need to do?

Ensure that the IMP/MD used in your study follows:

  • Applicable manufacturing guidelines, including any placebo product
  • Required transport guidelines (e.g. control over manufacturer/importer distribution chain, correct packaging and transport temperature)
  • Correct storage requirements (e.g. access control, applicable temperature-, light-, humidity conditions)
  • Regulatory labelling requirements (e.g. language, dosage, contact, coding to protect blinding)
  • Expiration information guidelines to guarantee for product stability and quality
  • Correct destruction procedures

For more information refer to Drug or Device in this Study Guide.

More

The Site-INV is responsible for the correct IMP/MD handling at the study site. This includes:

  • Instructions on actions to take when defined storage conditions are no longer met.
  • Applicable emergency processes are implemented in order to guarantee for the ongoing stability and quality of the investigational product.

The SP-INV provides the site with written instructions regarding the correct handling and storage of IMP/MD.

Where can I get help?

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

References

ICH GCP E6(R2) – see in particular guidelines

  • 1.33. Investigational product
  • 1.36. Investigator’s Brochure
  • 5.13 Manufacturing, packaging, labelling, and coding investigational product(s)
  • 5.14 Supplying and handling Investigational product(s)
  • 7. Investigator's Brochure

ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)

  • 6.5 Investigators brochure
  • 6.10.1 Labelling
  • 7.9 Investigational device accountability
  • Annex B Investigators brochure

GDP 2013/C 343/01 – see in particular

  • Good Distribution practices of medicinal products

EMA Suppl. Requirements, Annex 13 – see in particular

  • Guidance on good manufacturing and distribution practices

EudraLex Volume 4 EU Guidelines Good Manufacturing Practice, Annex 13 - see in particular

  • IMP
Abbreviations
  • CTU – Clinical Trials Unit
  • IB – Investigator Brochure
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/MD - Investigational Medicinal Product / Medical Device
  • IMP - Investigational Medicinal Product
  • ISO – International Organization for Standardization
  • MD - Medical Device
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Set-Up ↦ Management ↦ Investigational Product ↦ In Studies
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Set-Up ↦ Management ↦ Investigational Product ↦ In Studies

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