Set-Up↦Management↦Investigational Product↦In Studies
What is it? Why is it important?
In clinical studies Investigational Medicinal Product (IMP) or Investigational Medical Devices (IMD) 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:
- Dispensation and use
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.
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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 (access liable to cost) - see in particular sections
- 6.5 Investigators brochure
- 6.10.1 Labelling
- 7.9 Investigational device accountability
- Annex B Investigators brochure
GDP 2013 – see in particular
- Good distribution practices of medicinal products
EU GMP Annex 13 - see in particular guidance
- Guidance on good manufacturing and distribution practices
EudraLex Volume 4 EU - see in particular annex
- Annex 13, Good IMP manufacturing practice