What is an investigational medicinal product? The essential GCP guide
Every medicine that reaches patients has, at some point, existed as an investigational medicinal product, a compound that had to be tested, tracked, and rigorously controlled before regulators could confirm it was safe and effective enough for the general population. Yet despite the central role that the investigational medicinal product plays in clinical research, the term itself, along with the web of obligations surrounding it, remains poorly understood by many professionals new to clinical trials.
What exactly is an investigational medicinal product? How does it differ from an investigational product or an investigational drug? Who is ultimately responsible for it? And what do the ICH GCP E6(R3) guidelines, now adopted by both the FDA and the EMA, require in terms of storage, handling, accountability, and documentation?
This guide answers all of those questions. It is designed for investigators, clinical research coordinators, site pharmacists, sponsor representatives, CRAs, and anyone preparing for ICH GCP training or ICH GCP certification. Whether you are encountering IMP management for the first time or refreshing your knowledge ahead of a regulatory inspection, you will find a clear, authoritative, and practical explanation of every key concept.
What is an investigational medicinal product?
An investigational medicinal product, commonly abbreviated as IMP, is any medicinal product being tested or used as a reference in a clinical trial. This definition, as established by the European Medicines Agency (EMA) and reflected in global regulatory frameworks including ICH GCP E6(R3), is deliberately broad. It covers not only novel compounds in early development but also already-licensed medicines when they are studied in a new therapeutic indication, reformulated, repackaged, or when additional data are being collected about an already-authorized use.
If you are new to clinical research, you may first want to read our beginner’s overview: What is clinical research? 7 essential facts for beginners. Understanding the broader context of clinical trials will help you situate IMP management within its proper regulatory and scientific context.
In practical terms, an investigational medicinal product can be any of the following:
- A new chemical entity or biologic that has not yet received marketing authorization anywhere in the world.
- An already-approved medicine being studied for a new indication or population not covered by its current license.
- An approved medicine that has been reformulated or repackaged for the purposes of the trial, for example a new dosage form or concentration.
- A placebo used as a comparator or control in a blinded clinical trial.
- An active comparator that is a licensed product but is being used specifically within the context of a clinical trial.
Aligned to this definition, ICH GCP E6 R3 defines an investigational product as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorisation when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. Investigational products should be considered synonymous with drugs, medicines, medicinal products, vaccines, and biological products.
Understanding these concepts is foundational for anyone working in clinical research. Whether you are a clinical research coordinator, an investigator, a sponsor’s representative, or a regulatory professional, a clear grasp of what constitutes an investigational medicinal product is a prerequisite to fulfilling your responsibilities under Good Clinical Practice.
What does IMP mean in pharma?
In the pharmaceutical industry and clinical research community, IMP stands for investigational medicinal product. The term is used predominantly in the European regulatory context, where it has a specific legal definition under EU Clinical Trials Regulation (CTR) No. 536/2014. However, equivalent concepts exist globally. In the United States, the Food and Drug Administration (FDA) uses the term “investigational new drug” (IND) or simply “investigational drug,” while the broader ICH GCP framework uses “investigational product” (IP) as the overarching term.
The legal definition of an IMP in the EU is set out in the EU Clinical Trials Regulation No. 536/2014, which has applied to all trials approved through the CTIS portal since January 2023. Understanding this regulatory basis is particularly important for professionals working on multinational or EU-based trials.
The acronym IMP carries significant regulatory and operational weight. Its use in documentation, labeling, protocols, and standard operating procedures (SOPs) signals that the product is subject to specific requirements governing its manufacture, packaging, labeling, storage, distribution, dispensing, and accountability throughout the life of a clinical trial.
If you are pursuing ICH GCP training or working toward an ICH GCP Good Clinical Practice certification, you will encounter the term IMP repeatedly, as its management is one of the most operationally demanding and compliance-sensitive aspects of clinical trial conduct.
What is the difference between investigational products and investigational medicinal products?
This is one of the most frequently asked questions among professionals new to clinical research, and the distinction is important.
An investigational product (IP) is the broader term. Under ICH GCP E6(R3), an investigational product is defined as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization when used in a way not authorized or when used to obtain additional information on the authorized form.
An investigational medicinal product (IMP) is a subset of investigational products. The IMP classification applies specifically to products that meet the regulatory definition of a “medicinal product,” meaning they are intended to treat, prevent, or diagnose a disease, or to restore, correct, or modify physiological functions in humans. The IMP concept specifically excludes medical devices and other non-medicinal products that might be tested in a trial.
Key point: All investigational medicinal products are investigational products, but not all investigational products are investigational medicinal products. A medical device being evaluated in a clinical trial, for example, is an IP but not an IMP.
This distinction matters practically because IMPs are subject to a specific layer of regulation related to pharmaceutical manufacturing (GMP), pharmaceutical quality, and pharmacovigilance requirements that do not apply equally to all IPs.
What are investigational drugs?
Investigational drugs are a category of investigational products or investigational medicinal products that are chemical or biological pharmaceutical agents, as opposed to devices or non-medicinal interventions. The terms “investigational drug,” “study drug,” and “experimental drug” are often used interchangeably in clinical trial settings, particularly in the US context.
Investigational drugs include:
- Small molecule compounds in early-phase (Phase I, II) or late-phase (Phase III) development.
- Biologics, including monoclonal antibodies, gene therapies, cell therapies, and vaccines undergoing clinical evaluation.
- Off-patent licensed medicines being repositioned for a new indication.
- Approved drugs being studied in pediatric populations for the first time.
- Placebos matched to an active investigational drug.
From a GCP compliance perspective, investigational drugs must be manufactured in accordance with current Good Manufacturing Practices (cGMP), properly labeled, appropriately stored, and meticulously tracked. Any adverse experience that occurs during the administration of an investigational drug must be classified and reported in line with defined timelines. For a full explanation of those obligations, see our dedicated guide: Adverse Event Reporting in Clinical Trials: The essential ICH GCP guide.
What is investigational product (IP) management?
Investigational product management refers to the full set of processes, controls, and documentation activities that ensure an investigational medicinal product is handled appropriately from manufacture through to administration or disposal. Under ICH GCP E6(R3), IP management is a clearly defined responsibility shared between sponsors and investigators, with specific accountabilities assigned to each party.
Effective investigational product management encompasses the following stages:
- Manufacturing and quality release: The IMP must be manufactured in compliance with GMP standards and released by a qualified person before it can enter the clinical supply chain.
- Packaging and labeling: IMPs must be packaged to prevent contamination and deterioration during transport and storage. Labeling must comply with applicable regulatory requirements and, in blinded trials, must preserve the integrity of the blind while providing sufficient information for safe use. In the EU, IMP manufacturing and labeling are governed by Annex 13 of EudraLex Volume 4, the EU GMP guidelines. The current version, EudraLex Volume 4, Annex 13: Manufacture of Investigational Medicinal Products, sets out the GMP requirements for IMP packaging and labeling that EU-based manufacturers and sponsors must comply with.
- Shipping and distribution: The sponsor is responsible for defining acceptable shipping conditions and for ensuring that the product is shipped to investigational sites under conditions that maintain its integrity. Any deviation from specified shipping conditions must be evaluated and documented.
- Receipt and storage at site: Upon arrival at the investigational site, the IMP must be checked for integrity, counted, and logged. It must be stored under conditions specified by the sponsor, and temperature must be continuously monitored.
- Dispensing and administration: The IMP is dispensed and administered to trial participants according to the protocol and the sponsor’s instructions. All dispensing activities must be recorded.
- Return, destruction, or disposal: Unused or expired IMP must be returned to the sponsor or an authorized third party, or destroyed on site if permitted, in accordance with the protocol and applicable regulations. All these activities must be documented.
Understanding and implementing each of these stages is a core competency assessed in Good Clinical Practice training programs and is examined in Good Clinical Practice certification assessments.
What is clinical trial supply management?
Clinical trial supply management (CTSM) is the operational discipline dedicated to ensuring that investigational medicinal products and other trial supplies are available at the right place, at the right time, in the right quantity, and in the right condition throughout the life of a clinical trial. CTSM sits at the intersection of pharmaceutical manufacturing, logistics, regulatory affairs, and clinical operations.
Clinical trial supply management includes:
- Demand forecasting: estimating how much IMP will be needed based on enrollment projections, dosing regimens, and protocol-defined visit schedules.
- Manufacturing planning: coordinating with manufacturers or contract manufacturing organizations (CMOs) to ensure timely production and quality release of IMP batches.
- Packaging and labeling strategy: deciding on over-encapsulation, blinding strategies, kit design, and country-specific labeling.
- Interactive Response Technology (IRT): many modern trials use IRT systems to manage randomization, IMP assignment, and inventory levels automatically.
- Distribution and cold chain management: coordinating the movement of IMP from manufacturing sites to depots to clinical sites, while maintaining required temperature ranges.
- Returns and reconciliation: managing the return of unused IMP from sites, conducting reconciliation, and overseeing destruction or disposal.
CTSM failures can delay trials, compromise data integrity, and put participants at risk. This is why Good Clinical Practices training programs devote significant attention to IP management and why Good Clinical Practices certification increasingly requires demonstrated knowledge of supply chain principles.
The ICH GCP E6(R3) guideline has modernized expectations for how supply chain risks are assessed and managed. For a full analysis of what has changed under E6(R3) and how it affects all aspects of trial conduct, including clinical trial supply management, read our detailed post: ICH GCP E6 R3 implementation: what you need to know.
ICH GCP requirements for IMP handling, storage, and accountability
ICH GCP E6(R3) sets out detailed requirements for investigational medicinal product handling, storage, and accountability. These requirements apply to sponsors, investigators, and any service providers involved in the clinical supply chain.
These requirements flow from the overarching principles of ICH GCP, which in the E6(R3) version have been consolidated from 13 to 11 high-level principles, placing risk-based thinking and proportionality at the center of all trial activities. For a full explanation of those principles, see our dedicated guide: What are the principles of ICH GCP: the 2026 E6(R3) guide?.
IMP handling
IMPs used in a clinical trial must be managed in accordance with the product specifications and the trial protocol. Processes must be in place for the handling, shipping, storage, dispensing, returning, and destroying or alternatively disposing of the IMP. The sponsor must ensure that the IMP is characterized appropriately for the development stage, manufactured in accordance with applicable GMP, and coded and labeled in a manner that protects the blinding where applicable.
Investigators and site staff must follow the sponsor’s instructions for handling the IMP. They may only use IMP as directed by the protocol, and any deviation must be reported and documented.
Drug storage ICH GCP requirements
The sponsor must determine acceptable storage temperatures, storage conditions, for example protection from light, and shelf life for the IMP, and must inform all involved parties, including monitors, investigators, pharmacists, and storage managers, of these determinations.
At the investigational site, the IMP must be stored in a designated, secure area, accessible only to authorized personnel. Temperature monitoring must be continuous and documented. If a temperature excursion occurs, the deviation must be immediately reported to the sponsor, documented, and assessed to determine whether the affected IMP remains usable or must be quarantined and replaced.
Where are storage requirements for the investigational product usually found? Storage requirements are typically found on the IMP label affixed to the packaging and in the Investigator’s Brochure (IB). The trial protocol may also include specific storage guidance. Site staff should cross-reference all three sources to ensure they have the most complete and current requirements.
Storage conditions and shelf life are established through stability studies conducted in accordance with ICH Q1A(R2): Stability Testing of New Drug Substances and Products. Sponsors rely on the data generated in these studies to define the storage requirements communicated to sites via the IB and product labeling.
Investigational product accountability in clinical trials
Investigational product accountability refers to the complete, verifiable documentation of all IMP received, stored, dispensed, administered, returned, and destroyed or disposed of during a clinical trial. Accountability is not simply a regulatory formality; it is a critical tool for patient safety, data integrity, and fraud detection.
Accountability records must demonstrate a complete audit trail from receipt to final disposition. Responsibility for investigational product management, including accountability, handling, dispensing, administration, and return, rests with the investigator or institution. The sponsor may facilitate aspects of investigational product management by providing forms and technical solutions, such as computerized systems, and by arranging distribution of investigational product to trial participants.
At the site level, IP accountability is typically maintained in a drug accountability log. This log records every transaction involving the IMP at the site and is reviewed by monitors during monitoring visits.
During monitoring visits, monitors conduct IP accountability reviews as a standard component of site oversight. Under ICH GCP E6(R3), the frequency and depth of these reviews should reflect the risk level of the trial. For a comprehensive guide to how monitoring is structured under the latest GCP framework, see: Risk-Based Monitoring in Clinical Trials: the complete ICH E6 R3 guide.
Who has ultimate responsibility for an investigational product?
This is a question that arises frequently in GCP training and certification programs, and the answer is nuanced because responsibility is distributed across multiple parties.
- The sponsor: The sponsor bears ultimate overall responsibility for the investigational medicinal product throughout the supply chain. It is the sponsor’s obligation to ensure that the IMP is manufactured to GMP standards, properly characterized and released, correctly labeled, distributed under appropriate conditions, and that processes are in place to track and account for all IMP from manufacture to final disposition.
- The investigator or institution: Responsibility for investigational product management at the site, including accountability, handling, dispensing, administration, and return, rests with the investigator or institution. The investigator may delegate some or all of these activities to qualified site staff, such as a pharmacist or dedicated IP coordinator, but cannot delegate the underlying responsibility.
- Service providers: Contract research organizations (CROs), CMOs, central pharmacies, and logistics companies may be engaged by the sponsor to carry out specific activities related to IMP management. However, engaging a service provider does not transfer accountability. Both sponsors and investigators may delegate activities, but responsibility remains non-transferable.
Understanding this structure of accountability is essential for anyone taking ICH GCP training or seeking Good Clinical Practice certification. It is also a frequent topic in regulatory inspections and GCP audits.
In the United States, the sponsor’s responsibilities for IMP are codified in 21 CFR Part 312 (IND regulations). This federal regulation sets out the specific obligations sponsors must meet regarding IMP manufacture, labeling, shipping, and disposition and is the basis for FDA inspection findings related to IMP accountability.
Who is responsible for investigational product management at the site?
At the clinical site, the principal investigator (PI) holds overall responsibility for investigational product management. However, the day-to-day activities of IP management are typically delegated to specific team members:
- Pharmacist or pharmacy coordinator: In hospital-based or academic medical center trials, a qualified pharmacist often handles IMP receipt, storage, dispensing, and returns. The pharmacist maintains the drug accountability log and is the primary point of contact for IP-related queries from monitors.
- Clinical research coordinator (CRC) or Study Coordinator (SC) or IP coordinator: In sites without dedicated pharmacy resources, a trained CRC or IP coordinator may carry out IP management activities under the oversight of the PI.
- Sub-investigator: A sub-investigator with appropriate training may be delegated specific IP management responsibilities, such as reviewing accountability records or approving IP for dispensing.
All delegations must be documented on the site’s delegation of authority log, which is a required essential document under ICH GCP E6(R3). The PI must ensure that delegated personnel are appropriately trained before they carry out IP management activities.
It is also worth noting that the ethics committee overseeing the trial must be informed of the investigational product being used, and any significant protocol amendments, including those affecting IMP management, require ethics committee notification or approval before implementation. For an in-depth overview of ethics committee functions in clinical trials, see: 7 essential roles of an ethics committee in clinical trials.
IP chain of custody documentation
The chain of custody for an investigational medicinal product refers to the chronological documentation that traces the IMP from the manufacturer to the clinical site, from the site’s secure storage to each individual participant, and from any unused product back through the return and destruction process.
A complete IMP chain of custody includes the following elements:
- Shipping records and delivery receipts, including temperature monitoring records for the shipment.
- Inventory logs recording all IMP received, including batch or lot numbers, expiry dates, quantities, and storage location.
- Drug accountability logs capturing every dispensing event, including participant ID, date, quantity dispensed, lot number, and name of dispenser.
- Destruction or return records documenting the quantity, lot number, destruction method, and witness signatures for all IMP returned or destroyed.
Monitors review chain of custody documentation at every monitoring visit and must confirm that there is no unexplained discrepancy between quantities received, dispensed, returned, and remaining in inventory. Any discrepancy is considered a serious finding and must be investigated.
ICH GCP E6(R3) has introduced enhanced data governance expectations that apply to IMP chain of custody records. Where paper-based or electronic records are maintained, they must now meet a full “data life cycle” model, covering capture, integrity, access controls, and retention. To understand how E6(R3) differs from the previous E6(R2) on these and other documentation requirements, see our detailed comparison post: key changes between ICH GCP E6 R3 and E6 R2.
Where is investigational product dispensing information recorded?
Investigational product dispensing information is recorded in the drug accountability log maintained at the investigational site. This document is the primary source record for all IMP dispensing activities.
The drug accountability log typically captures:
- Date of dispensing.
- Participant identification number, not personal identifiers, to maintain blinding and privacy.
- Quantity dispensed, in number of units, vials, tablets, or other dosage units.
- Batch or lot number of the dispensed IMP.
- Expiry date of the dispensed IMP.
- Name and signature of the person who dispensed the IMP.
- Return date and quantities returned by the participant, if applicable.
- Any notes regarding missed doses, dose modifications, or discrepancies.
In some trials, particularly those using IRT systems, dispensing may be guided and recorded electronically. In these cases, sites are still typically required to maintain a parallel log at the site level, as specified in the sponsor’s IP management instructions or pharmacy manual.
Temperature monitoring and deviations for IMP
Temperature control is one of the most operationally demanding aspects of investigational medicinal product management. Many IMPs, particularly biologics and cell-based therapies, require continuous cold chain maintenance from manufacture to administration. Even products stored at room temperature may be adversely affected if temperatures exceed or fall below defined limits.
Temperature monitoring requirements
The sponsor must define acceptable temperature ranges for the IMP and communicate these clearly to site staff. These ranges must be monitored continuously using validated equipment. Many sponsors require continuous electronic temperature monitoring with alarm functionality, regular review and documentation of temperature records, calibration certificates for monitoring equipment, and a defined process for managing temperature excursions.
For biological IMPs such as vaccines or cell-based therapies, cold chain requirements can be particularly stringent. The WHO guidelines on maintaining the cold chain for pharmaceutical products offer additional practical guidance that complements sponsor instructions, especially for sites in low-resource settings or where cold chain infrastructure is limited.
Handling temperature deviations
When a temperature deviation occurs, meaning the temperature falls outside the defined acceptable range, the site must:
- Immediately quarantine the affected IMP to prevent inadvertent use.
- Document the deviation, including the date, time, duration, temperature reached, and circumstances.
- Notify the sponsor or CRO monitor as soon as possible.
- Await sponsor instructions before using the affected IMP.
The sponsor will conduct a stability-based assessment of the deviation and will issue written guidance on whether the affected IMP can still be used, must be replaced, or must be destroyed. This guidance must be filed in the site’s essential documents as part of the IMP-related records.
Investigational product retention period
The retention period for investigational medicinal product records refers to how long documentation related to IMP management must be kept after the end of the trial. This includes drug accountability logs, shipping records, temperature monitoring logs, and deviation reports.
ICH GCP E6(R3) requirement: The investigator should retain the essential records for the required retention period in accordance with applicable regulatory requirements. In the EU, this can be up to 25 years.
In the United States, FDA regulations under 21 CFR Part 312.62 require investigators to retain records for a minimum of two years following marketing approval of the drug, or two years after the investigation is discontinued and the FDA notified. In practice, most sponsors instruct sites to retain essential documents, including IMP records, for a minimum of 15 years, though this may vary by study, sponsor policy, and regulatory jurisdiction.
The sponsor is responsible for informing investigators of the applicable retention period and for notifying investigators when records may be destroyed. Investigators must not destroy IMP records without the sponsor’s prior written permission.
Understanding retention requirements is a standard component of Good Clinical Practices training and is examined in Good Clinical Practices certification programs.
What is a non-investigational medicinal product (NIMP)?
A non-investigational medicinal product (NIMP) is a medicinal product that is used in a clinical trial but is not itself the subject of investigation. NIMPs are products that support the conduct of the trial without being the test or comparator product.
Common examples of NIMPs include:
- Rescue medications used to manage adverse events or trial-related symptoms in participants.
- Medications used for background therapy that is standardized across all participants.
- Diagnostic agents used in trial procedures but not being evaluated for their own efficacy or safety.
- Challenge agents used to provoke a physiological response being measured in the trial.
NIMPs are distinct from IMPs in the EU regulatory framework but may still be subject to specific handling, storage, and documentation requirements defined by the sponsor in the trial protocol or in separate NIMP instructions. While NIMPs are generally not subject to the same GMP labeling requirements as IMPs, they must still be of appropriate pharmaceutical quality and must be managed in a way that does not compromise participant safety or data integrity.
The European Commission has published specific guidance on the boundary between IMP and NIMP: Definition of Investigational Medicinal Product (IMP) and use of Auxiliary Medicinal Products (AMPs) (European Commission guidance). This guidance is essential reading for EU clinical trial teams managing complex multi-arm or adaptive studies where the IMP/NIMP boundary may not be straightforward.
Investigational medicinal products in clinical trials: a regulatory overview
The regulatory framework governing investigational medicinal products in clinical trials is multi-layered, involving international guidelines, regional regulations, and national laws.
At the international level, ICH GCP E6(R3), finalized in January 2025 and adopted by the FDA in late 2025, sets the foundational good practice requirements. ICH Q guidelines govern pharmaceutical quality and GMP for IMP manufacture. ICH E8(R1) provides guidance on general considerations for clinical studies and is closely linked to ICH GCP E6(R3).
In the European Union, the Clinical Trials Regulation (EU CTR No. 536/2014) provides the legal framework for the authorization, conduct, and oversight of clinical trials. It establishes specific requirements for IMP and NIMP, including GMP compliance for IMP manufacturing, labeling requirements for blinded and unblinded trials, and procedures for managing IMP deviations.
In the United States, the FDA’s IND regulations (21 CFR Part 312) govern the use of investigational new drugs in clinical trials. For a comprehensive overview of the latest GCP requirements, read the FDA’s E6(R3) guidance and the full ICH E6(R3) text published by the EMA.
It is also worth understanding that the ethical obligations underpinning all of these regulatory requirements, including those for IMP management, trace back to foundational documents in research ethics. The principles of respect for persons, beneficence, and justice that the Belmont Report codified in 1979 are reflected directly in the GCP requirements for participant safety and data integrity that govern how IMPs are managed today. For an accessible introduction to those ethical foundations, see: The Belmont Report: 3 powerful principles that protect patients.
For anyone working in a global or multinational trial context, navigating these overlapping regulatory frameworks requires a solid foundation in good clinical practice. ICH GCP certification from an accredited provider like PharmaEduCenter provides this foundation. You can also access a range of free GCP resources to supplement your learning.
Key takeaways
- An investigational medicinal product (IMP) is any medicinal product tested or used as a reference in a clinical trial, including unapproved drugs, approved drugs in new indications, and placebos.
- The terms investigational product (IP) and investigational medicinal product (IMP) are related but not identical: all IMPs are IPs, but not all IPs are IMPs.
- Under ICH GCP E6(R3), ultimate responsibility for investigational product management at the site rests with the investigator or institution.
- The sponsor bears ultimate overall responsibility across the entire supply chain.
- Storage requirements are typically found on the IMP label and in the Investigator’s Brochure (IB).
- Investigational product dispensing information must be recorded in drug accountability logs.
- The minimum retention period for IMP records is determined by applicable regulatory requirements, which in the EU can be up to 25 years.
- Non-investigational medicinal products (NIMPs) are products used to support a trial but not themselves under investigation.
- Thorough GCP training and ICH GCP certification from PharmaEduCenter equip professionals for every aspect of IMP management.
Conclusion
The investigational medicinal product is at the heart of every interventional clinical trial. Whether you are a sponsor building a supply chain, an investigator responsible for on-site management, or a coordinator maintaining the drug accountability log, understanding what constitutes an investigational medicinal product, who is responsible for it, how it must be stored and handled, and how every transaction must be documented is essential to conducting clinical research that meets GCP standards.
ICH GCP E6(R3) has reinforced and modernized these requirements, emphasizing risk-based approaches, clear delegation of responsibility, and robust documentation across the full IMP lifecycle. As regulators worldwide, including the FDA and EMA, move to full implementation of E6(R3), professionals with up-to-date knowledge of IMP management requirements will be more valuable than ever.
If you want to make sure you are fully across the latest GCP requirements for investigational medicinal products, read our comprehensive overview of what a Good Clinical Practice certification covers in 2026. And if you are considering a career in clinical research and wondering how GCP certification can open doors, see our guide on how to land entry-level clinical research jobs.
If you want to ensure that you and your team are fully equipped to manage investigational medicinal products in compliance with the latest GCP standards, explore PharmaEduCenter’s accredited ICH GCP training and ICH GCP certification programs. Our courses are approved by TransCelerate and accredited by the Faculty of Pharmaceutical Medicine, and they are trusted by over 6,000 certified professionals worldwide.
🎓 Click here to start your ICH GCP Certification at PharmaEduCenter today.
FAQ: adverse event reporting in clinical trials
What is an investigational medicinal product?
An investigational medicinal product (IMP) is any medicinal product being tested or used as a reference in a clinical trial. This includes unapproved new drugs, approved drugs being studied in new indications or formulations, active comparators, and placebos.
What does IMP stand for in pharma?
IMP stands for investigational medicinal product. The term is used primarily in the European regulatory context and is equivalent in concept to “investigational drug” or “study drug” used in other regulatory frameworks.
What is the difference between an IP and an IMP?
An investigational product (IP) is the broader term and includes any product tested in a clinical trial, including medical devices and non-medicinal products. An investigational medicinal product (IMP) is a subset of IPs that meets the definition of a medicinal product. All IMPs are IPs, but not all IPs are IMPs.
Who has ultimate responsibility for an investigational product?
The sponsor bears ultimate overall responsibility for the investigational product across the entire supply chain. At the investigational site, the investigator or institution is responsible for IP management, including accountability, handling, dispensing, administration, and return. The investigator may delegate activities but not the underlying responsibility.
Where are storage requirements for the investigational product usually found?
Storage requirements are typically found on the IMP label and in the Investigator’s Brochure (IB). The trial protocol may also contain storage specifications. Site staff should consult all applicable sources and follow the most restrictive requirements in cases of discrepancy.
Where is investigational product dispensing information recorded?
Investigational product dispensing information is recorded in the drug accountability log maintained at the investigational site. This log captures the date, participant ID, quantity dispensed, batch number, expiry date, and name of the dispenser for every dispensing event.
What is the investigational product retention period?
The retention period for IMP records depends on applicable regulatory requirements. ICH GCP E6(R3) requires investigators to retain essential records for the period specified by applicable regulations, which in the EU can be up to 25 years. In the US, FDA regulations specify a minimum retention period linked to the development timeline of the drug. Investigators must not destroy records without the sponsor’s written permission.
What is a non-investigational medicinal product?
A non-investigational medicinal product (NIMP) is a medicinal product used in a clinical trial that is not itself the subject of investigation. Examples include rescue medications, standardized background therapy, and diagnostic agents. NIMPs are distinct from IMPs but may still require specific handling and documentation.
How does Good Clinical Practice training help with IMP management?
GCP training provides clinical trial professionals with a thorough understanding of the regulatory requirements and practical expectations for IMP management, including handling, storage, accountability, chain of custody, and deviation management. ICH GCP certification from an accredited provider validates that professionals have this knowledge and are equipped to apply it in their roles.
What happens if an SAE is not reported within the required timeline?
Late or missed SAE reporting is a GCP violation. It may be flagged as a finding at a monitoring visit or regulatory inspection, classified as a protocol deviation or serious GCP violation depending on severity, and may result in action by the sponsor, including site retraining, increased monitoring frequency, or in serious cases, site suspension. In the most severe cases, where unreported or delayed SAEs are found to have affected participant safety across multiple sites, regulatory authorities may place a clinical hold on the entire study.
