The CRC Toolkit: Drug Accountability Calculator
Investigational Product (IP) Compliance Calculator
Quick Disclaimers:
- For simple data entry aid for countable drug units (pills, tablets, patches, etc.). Not for liquids measured by volume.
- Verify all calculations and protocol.
- NO PHI. Not for medical advice.
- See 'About' tab for full disclaimers.
Important Note for Different Strengths/Types of Medication:
This calculator helps you track one type of pill or unit at a time (like "10mg tablets" OR "50mg capsules"). If a patient takes different strengths or types of pills to make up their full daily dose (for example, two 10mg pills AND one 50mg pill), please do a separate calculation for each type of pill. This helps make sure each medication is tracked correctly.
About The CRC Toolkit: Drug Accountability Calculator
This Drug Accountability Calculator, part of The CRC Toolkit, is a simple tool designed to assist clinical research coordinators and site staff with common calculations related to investigational product (IP) accountability for countable dosage forms (e.g., pills, tablets, capsules, patches) at the subject level. Its primary goal is to provide quick mathematical support for data entry tasks, focusing on IP consumption and subject compliance rates. It includes an optional field to account for units reported lost or damaged by the subject for more precise calculations. This tool is not intended for liquid medications measured by volume.
Important Note for Different Strengths/Types of Medication: This calculator helps you track one type of pill or unit at a time (like "10mg tablets" OR "50mg capsules"). If a patient takes different strengths or types of pills to make up their full daily dose (for example, two 10mg pills AND one 50mg pill), please do a separate calculation for each type of pill. This helps make sure each medication is tracked correctly.
Important Disclaimers
- For Informational & Data Entry Aid Purposes Only: This calculator is intended solely for simple data entry assistance and informational purposes within the context of clinical research drug accountability for countable drug units.
- Not for Medical Advice: The information and calculations provided by this tool should NOT be considered medical advice or used for making clinical decisions. Always consult with qualified healthcare professionals and refer to the study protocol for any medical or treatment-related guidance.
- No Protected Health Information (PHI): Users must NOT enter any Protected Health Information (PHI) or any other sensitive personal data into this calculator. The tool is designed for anonymized calculation purposes only.
- Independent Verification Required: All calculations and outputs from this tool MUST be independently verified by the user against source documentation, study protocols, and applicable Standard Operating Procedures (SOPs). Users are responsible for ensuring the accuracy and appropriateness of all data entered and results obtained. Consider discussing discrepancies with the patient (e.g., regarding lost/damaged units, dosing misunderstandings) as per site SOPs and protocol.
- No Liability: The creators and providers of this tool are not liable for any errors, omissions, inaccuracies, or any direct or indirect consequences arising from the use of this calculator. Users assume full responsibility for their use of this tool.
- Compliance with Regulations and Protocol: Use of this tool does not replace or supersede any regulatory requirements (e.g., FDA, EMA, ICH GCP), institutional policies, or specific study protocol directives regarding drug accountability. Always adhere to all applicable guidelines and regulations.
- Tool Limitations: This calculator is a simplified tool and may not cover all aspects or complexities of drug accountability required for every clinical trial. It focuses on basic subject-level calculations. More comprehensive site-level reconciliation and inventory management may require more sophisticated systems or processes.
Resources for Clinical Research Professionals
The following resources provide valuable information on drug accountability, Good Clinical Practice (GCP), and regulatory guidelines relevant to clinical trials.
Key Regulatory Bodies & Guidelines:
- FDA Clinical Trials Guidance Documents (U.S. Food and Drug Administration)
- FDA 21 CFR Part 11 (Electronic Records; Electronic Signatures)
- EMA Clinical Trials in Human Medicines (European Medicines Agency)
- EMA Clinical Trials Regulation (EU) No 536/2014
- ICH Efficacy Guidelines (including ICH E6 - Good Clinical Practice) (International Council for Harmonisation)
General Drug Accountability & Clinical Trial Management:
The following are examples of topics and types of resources that are important. Specific links can be found in the "Drug Accountability Calculator Resources" document provided or through targeted searches on the respective organization's websites.
- CDISC Standards: (e.g., CDISC SDTM for data tabulation, which can include drug accountability domains).
- Investigational Product Management SOPs: Many academic institutions and research organizations publish templates or examples of SOPs for IP management (e.g., searching for "Investigational Drug Services SOP" from university research sites).
- Articles and White Papers on Drug Accountability: Publications from industry groups, CROs, and regulatory affairs organizations often discuss best practices and challenges (e.g., searching on sites like Applied Clinical Trials, MasterControl, etc.).
- Resources from Professional Organizations: Groups like ACRP (Association of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) often provide educational materials and guidelines.
The following are illustrative examples of specific resources:
- MasterControl: Ensuring Drug Accountability in Clinical Trials
- Georgetown University: Resources for Clinical Researchers
- NCCIH: Investigational Product Accountability Log: Subject Record (DOCX download)
- Almac Group: ART™ – Drug Accountability & Reconciliation Tracking
This "Resources" page is intended to provide starting points for further information. Always prioritize official regulatory documents, study-specific protocols, and your institution's SOPs.