Table of Contents • Overview • Database entry • Areas involved in Data Entry Function of Database • Sources of AEs and form of Data Received • Different ways of arrival of Data • Types of Data Entry • Outsourcing for data entry • Head quarter data entry • Geographic data entry by region • Country data entry • Data entry unit • Critical issues data entry • Data elements • Steps of data entry
Overview of Data Entry Any company that receives more than a handful of AEs, whether for marketed products or for products only in clinical trials, needs a database to collect, assemble, and report on these AEs. It is necessary to have an AE database that allows, a minimum, either easy data entry manually and by E2B or a customized upload, preparation, and printing of MedWatch and CIOMS.
Database Entry • At this point, the case should be entered into the computerized safety database. • If case is received electronically, should be reviewed in “holding area” before uploading into the safety database and tested for trusted source • Manual data entry should be done for cases that arrive manually using a standard data collection form Sources of manual data Case report form Handwritten notes CIOMS I/Med Watch forms Hospital records Physicians’ notes Telephone reports
Database Entry Continue.. • Companies have initial review by a medical professional who highlights terms for data entry Other companies send source documents directly to data entry group and perform reviews later • If a case number (control number/medical reference number) has not been assigned at triage, it is done now • MedDRA coding of AEs, medical histories and drug coding is done by drug safety group or dedicated coding group • Case narrative is written. Narratives should be written in a standard way in terms of format, content, follow up information, etc. • Narrative is the key summary of the case and should be a good “stand-alone” summary of a case
Areas involved in Data Entry Function of Database • Upload capabilities from other databases or via E2B. • Tabular entry of laboratory data as well as manual entry. • Multiple narratives for the same case. • Ability to handle multiple labels. • Ability to handle one or more reporter for a single case. • Tracking of information in and out. • Duplicate check for cases using multiples. • Ability to add fields as needed. • Ability to close/complete a case and reopen it as needed. • Edit checks. • Spell check in multiple languages. • Ability to handle combination drugs, drug devices, OTC, and so forth.
Sources of AEs and form of Data Received There are different types of sources, such as; • Solicited sources (solicited reports are those derived from organized data collection systems such as clinical trials, registries, post-approval patient use programs, other patient support, disease management programs, surveys of patients or healthcare providers, or information gathering on efficacy or patient compliance). These kind of sources are not considered spontaneous. • Unsolicited sources (also called spontaneous reports) ( a spontaneous report is an unsolicited communication by a healthcare professional, or consumer to a company, regulatory authority or other organizations that describes one or more adverse drug reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection.
Different ways of arrival of Data There are so many a data or a report can arrive to a company- • Cases can be received from primary sources like patient, healthcare professional, consumers or lawyers. • Another source of case is from literature reports published in magazines, journals etc. • It can also be received from health agencies by means of MedWatch forms, CIOMS-1 form, VAERS form. • Other sources are clinical studies, spontaneous reports, stimulated reports, legal cases. • The above sources can be received via phone, fax, email, website, reports to sales representative etc.
Types of Data Entry • Companies make strategic, organizational, and operational decisions on where data entry should occur, esp. if they are multinational companies. This streamlines operations and allows for standardization across all data entry personnel and for backup data entry if one site should go out of service so companies respond to these needs in multiple ways: • Headquarter data entry – for small companies or AEs from only one or two countries, it is sometimes feasible to ship all AEs to the main drug safety dept for data entry. • Geographic data entry – one (or sometimes two) regional data entry center each for North America, Europe, South America, and Asia/Africa. Follow up of cases is done locally in the local language and the data transmitted to the regional data center for entry into the corporate safety database. • Country data entry – some companies have more dispersed entry than by region. They may designate major affiliates or subsidiaries, particularly those with high volumes of AEs, to do data entry for their country.
Outsourcing for data entry Types of Data Entry • Sometimes Companies may hire CROs to do data entry for them, shipping completed cases for review back to the company. • This could occur for all cases or only for those cases in a country where the company chooses not to set up a data entry function. • Some countries handle clinical trial data entry separately from post marketing data entry even if the data goes into the same safety database.
Critical Issues: Data Entry • Maintaining standards and consistency across multiple and diverse data entry sites, often speaking different languages and working under different conditions and time zones is always challenging. • Organizational reporting may also present issues if the safety personnel abroad report only locally and not “dotted line” or directly to the head safety office. • Training is harder over greater distances even with online and other high-tech training tools. • Time zones interfere with workflow. • Quality is harder to measure and maintain. • IT issues occur in terms of storage, networks, security, data transmission speed, and support.
Steps of Data Entry Company receive Adverse events cases and data is being entered into drug safety database • Inbox screen • Summary Screen • Case ID screen • Patient screen • Medical History Screen • Drug History Screen • Reaction Screen • Drug Screen • Reporter Screen • Narrative Screen • Diagnostic Screen • Processing Functions Screen
Inbox Screen This screen usually has a list of the AEs, with the date received, level of seriousness and the level of priority.
Summary Screen- This screen usually has the summary of an individual’s case pertaining to his reporter, patient info, med, drug and reaction
Summary Screen Case Identification Report Type Literature Primary Author Citation: Author 1, Author 2, Title of article, Title of journal, Issue date, Volume number, Page numbers Seriousness Medically Confirmed Classification Case Characteristic Date 0 version received Latest information received date Local Case ID Study Protocol number Investigator number Center number Medication number CRF number Reporter Patient Medical History Drug History Reaction Drug Narrative Diagnostic Qtech- Sol Professional Development Center, NJ, USA.
Case ID • Initiating company unit • Country of primary source • Country where AE occurred • Local case ID • Case Priority • Version Dates • Version initially received • Received by case processing center • Report Type • Classification • Nature of complaint • Case Characteristic • Received by local safety unit • Medically confirmed Yes No • Regulatory relevant update Yes No • Seriousness • Other Identification numbers
Patient screen Patient ID Patient Sex Date of Birth Age Age group Height Weight Date of last menstrual period Physician aware of adverse event Yes No Unknown Permission to contact Physician Yes No Unknown Death Date of Death Was Autopsy done? Date of Autopsy Patient Numbers General Practioner Record number Medical Specialist Record number Hospital Record number Social History Numbers of cigarettes per day Number of years smoked Numbers of drinks per day Type of alcohol Physical activity Patient other history Pregnancy Previous pregnancies Current pregnancy Expected date of delivery Did mother experienced any medical problems Any relevant information from father Current pregnancy outcomes Clinical status of pregnancy Clinical condition of fetus
Medical history screen • Reported Diseases/Surgical Procedures: • Low level term : • Preferred term : • Start date : • End date : • Comments :
Drug History Screen • Reported Drug Name: • Generic drug name: Quitex • Start date:12 Jan 2011 • End Date: • Route of administration:Oral • Reported Indication: Hypothyroidism • Coding • Low level term: ____________________________ • Preferred term: ____________________________
Reaction Screen Reported Reaction: Pulmonary embolism Coding Low level term: ____________________________ Preferred term: ____________________________ Serious: Yes No Outcome: Recovered Not Recovered Recovering Fatal Unknown Date Reaction Started:16 Jan 2011 Date Reaction Ended:19 Jan 2011 Reaction Duration:
Drug Screen Made by: Company drug Non-company drug Coding Reported drug name: SUSPECT DRUG BRAND NAME Generic Drug Name: GENERIC NAME:Quitex Characterization: Suspect Suspect Drug Interacting Concomitant Action taken with drug: Discontinued Dose formulation: Rout of administration: Oral Drug treatment duration Dose:5mg Frequency Unit Drug start date:12Jan2011 Drug end date: First reaction occurred with drug:Pulmonary embolism Drug Indication: _____________________ Coding Low level term: _____________________ Preferred term:_____________________ Batch numbers Rank Lot number Expiration date: Product Complaint number Date sent to QA Investigation Result Description
Reporter Screen Qualification Title Given Name Middle Name Family Name Degree Address Department Organization Contact information Company representative information Due-diligence Request
Narrative Screen Upon completion of all the data entry narratives are drafted.
Finally, a safety database is both a core element of any Pharmacovigilance system and a legal pre-requisite for pharmaceutical companies, wishing to place a medicine or medicinal product onto any EU market as per E2B. These companies will and still need to strive in entering the accurate data with the system over the years . Summary