Table Of Content

AUTHOR INDEX TO VOLUME 7 Abell M, 110A Due DL, 48A Alderman JL, 47A Durbin PM, 107A Allen A, 103A Anderson CR, 115A Edgar PP, 147 Anderson JL, 103A Edwards LD, 17 Arnett D, 119A Enas GG, 193 Bala Subramanian V, 25 Faich GA, 107A Barbarash RA, 41A Falk JI, 53A Barbetti P, 46A, 53A Felch L, 65 Beaty R, 51A Ferzola N, 119A Becker R, 54A Flanagan D, 111A Berry P, 181 Funderburk FR, 3, 65 Berzon RA, 203 Bigelow GE, 65 Gergits MA, 47A Birtwistle D, 139 Gibbons-White S, 111A Blackmon P, 115A Glasser S, 119A Bleicher R, 109A Gorski CM, 109A Bolash NK, 118A Grable D, 41A Borgen LA, 106A Griffiths CEM, 101A Boxx LS, 104A Griffiths RR, 65 Bresnick PA, 17 Grove PL, 113A Breton L, 51A Buhay N, 154 Haire WD, 109A Buonagura AM, 115A Halloran L, 49A, 118A Butterworth B, 43A Harman E, 51A Byrne BJ, 48A Harvey M, 115A Hawkins C, 119A Caldwell RW, 25 Hendeles L, 51A Campanaro E, 111A Hernadi E, 110A Carey LA, 111A Herzog H, 104A Carlson J, 106A Himmel JK, 116A Cavanaugh S, 117A Hyland D, 44A, 116A Chandler J, 46A Chandler JF, 114A Jeyashree S, 25 Chaponis RJ, 17 Johnston DB, 31 Cocchetto D, 174 Cocchetto DM, 121 Kahn SM, 107A Cone KR, 107A Karagounis LA, 103A Cook ME, 115A Kessler DA, 183 Craig MT, 104A Koehn KR, 107A Koffer H, 107A Davidson JA, 114A Kotulak GD, 109A Davis DD, 42A DeGaetano C, 52A Lange W, 54A, 102A, 114A Dockhorn DW, 45A, 102A Lea DE, 108A, 112A Dornbierer M, 46A Liang M, 112A Journal of Clinical Research and Pharmacoepidemiology 7, 257-258 (1993) © 1993 Associates of Clinical Pharmacology Published by Elsevier Science Publishing Co., Inc. 257 655 Avenue of the Americas, New York, NY 10010 0889-58 13/93/$6.00 Author Index J. Clin. Res. Pharmacoepidemiol. 7:257—258 (1993) Liebson IA, 65 Rowan AJ, 43A, 52A Lindsey T, 44A Liu HH, 118A Santoro J, 5OA Lubina JA, 123 Saunders M, 130 Schwartz AM, 100A Schwartz R, 41A Mackenzie A, 65 Searight HR, 41A Magid A, 105A Seeley P, 111A Margiti¢ SE, 243 Shanmugam M, 25 Martin M, 161 Shellabarger S, 102A McClees NJ, 109A Simeon GP, 203 McCoy H, 106A Simonyi LK, 41A McDermond T, 114A Simpson RL Jr, 203 Miller CK, 41A Sims MP, 43A Molino L, 51A Sirgo MA, 49A Morgan JP, 3 Stagg A, 127 Myers T, 106A Stephens LC, 109A Stevenson JG, 41A Nagarajan R, 25 Steward N, 54A Nagle B, SOA Strickler SW, 51A Nappi A, 50A Summerfelt A, 3 Neace S, 101A Summers K, 103A Swarbrick J, 127 Ogle C, 101A Tilson HH, 233 Papke A, 77 Toscani M, 46A, 53A Papke RA, 44A, 116A Townsend KC, 113A Tucker R, 101A Parmentier J, 127 Tuttle RR, 25 Parry JL, 105A Pederson J, 51A Vien C, 111A Peng A, 49A Von Tress M, 54A Pietruszka MH, 99A Powers F, 110A Wallin JD, 115A Price M, 54A, 114A Weinhold LL, 3 Priesmeyer C, 119A Weiss RR, 17 West T, 119A Resnick G, 46A Resnick GD, 53A Young LM, 113A Roskelley M, 103A Roulia V, 101A Zanecchia D, 54A Routh I, 105A Zerbe RL, 193 SUBJECT INDEX TO VOLUME 7 ABBREVIATIONS Establishing an Effective Communication The PF (Pitfalls) of B (Brevity), 77 System for Decentralized Monitors, 106A ABSTRACTS **False Positive’ Urine Screen for ACP Spring 1992 Poster Abstracts, 41A- Opiates Following Consumption of S55A Poppy Seed Muffins, 106A ACP Spring 1993 Poster Abstracts, 99A- Global Project Management: A Clinical 120A Research Organization Perspective, 53A Circadian Rhythm of Erythropoietin in Humans, 99A Handling Waste in the Clinical Research The Clinical Quantification of Setting, 46A Photoaging, 101A How to Assist the Paper Flow in Clinical Research in the Group Practice Conducting Clinical Research Studies, SIA Setting, 101A Clinical Trial Management by a Hospital How to Develop a Relational Database to Pharmacy-Based Clinical Research Expedite the Investigator Selection Division, 41A Process for Clinical Trials, 107A Comprehension and Recall of the How to Implement a Phase I Protocol, Informational Consent of the Informed S52A Consent Document: An Evaluation of Innovative Approaches to the Conduct of 168 Patients in a Controlled Clinical Large-Scale Controlled Clinical Trials, Trial, 41A 107A Computer-Automated QA for Phase I/II Inpatient Pharmacokinetic Studies: Clinical Trials, 102A Improving Safety, 108A Confidentiality Issues, Results, and Integration of a Continuous Quality Demographics in Reporting Research Improvement Process at an Subjects’ Laboratory Results, 47A Investigative Site, 54A Design Considerations for Anti- Investigator Reference Guide Study, Hypertensive Trials in the Elderly, 49A 109A Direct-From-Patient-InformationsM Keying Case Report Form Design to (DFPI). A Unique Concept for Clinical Medical Behavior and Medical and Marketing Research, 102A Documentation Practices, 442A Does Entry into Thrombolysis Trials Maximize Subject Enrollment, Minimize Adversely Affect Time-to-Treatment? Time and Effort: Get the Fax, 109A A Pilot Comparison in an Unblinded, Measurement of Recovery Time as an Non-randomized, Parallel Group Study Endpoint for Exercise Challenges in and Nonstudy Patients, 103A Asthma, 51A Drug Inventory Utilizing Wordperfect A Microcomputer-Assisted Methodology 5.1’s Table Feature, 44A for the Selection of Matched Controls Elderly Population in Sequestered in a Multisite Case-Control Study, Clinical Trials, 104A 100A Emergency Medicine Research in the Multicenter Trial Strategies: An Audio/ Prehospital Setting: Strategies of the Visual Approach to Augment Study Brain Resuscitation Clinical Trial, Personnel Training, 46A 104A A New High Speed Monitoring and Data Entry-Level Clinical Research Associate Entry System, 45 Training Course, 105A Ongoing Database Creation, 110A Journal of Clinical Research and Pharmacoepidemiology 7, 259-259-266 (1993) © 1993 Associates of Clinical Pharmacology Published by Elsevier Science Publishing Co., Inc. 259 655 Avenue of the Americas, New York, NY 10010 0889-58 13/93/$6.00 Subject Index J.Clin. Res. Pharmacoepidemiol. 7:257—259-266 (1993) Organizational Challenges in SWAT Use of FAX Technology for In-House Project Management, 43A Monitoring of CRFs, 43A Patient Satisfaction with Participation in a Use of Project-Specific Development Clinical Trial, 48A Plans for CRA Training, 118A Patient’s Perception of Financial Impact Why Do Patients Participate in Clinical of HIV Treatment, 111A Research?, 119A Phase IIIB Clinical Trials: A Management Why Do Patients Respond to Newspaper Strategy for the Nineties, 111A Advertisements for Clinical Trials?, Practically Interfacing . .. The Clinical 119A Investigations Unit, 112A Prevention is the Best Medicine: A ACRONYMS Proactive Approach to a Quality, The PF (Pitfalls) of B (Brevity), 77 Analyzable Database, 113A Quality Assurance and the ADINAZOLAM Implementation of SOPs During Behavioral Evaluation of Drugs: A Clinical Trials, 113A Comparison of the Behavioral Effects Quality of Life in the Elderly Patient After of Adinazolam and Lorazepam, 65 Open Heart Surgery, 47A Readability of the Patients’ Informed ADVERSE EVENT REPORTING Consent: A Continuing Problem in Commentary, 181 } Clinical Trials, 54A Introducing MEDWatch: A New Reducing Case Report Form Corrections Approach to Reporting Medication and Through Use of a Standardized Case Device Adverse Effects and Product Report Form Analysis System, 114A Problems, 183 Remote Entry to Integrated Clinical Project Database: On-Line Reporting AGED. See ELDERLY of Clinical Trial Site Visit Information by Clinical Research Associates, 5OA ANALGESIA Skills Assessment of Clinical Research Reversal of Effects of Morphine by Associates (CRAs), 49 Nalmefene, 25 Skin Test Documentation: A Tape Transfer Method, 114A ANTIEMETIC Source Documentation in the Form of Lessons Learned From Coordinating a Protocol-Specific Clinic Visit Sheets, Pivotal Clinical Trial, 31 115A A Standardized Format for On-Site ASTHMA Monitoring Trip Reports, 52A Measurement of Recovery Time as an Techniques for Ensuring Patient Endpoint for Exercise Challenges in Compliance Through Study Design Asthma, 51A and Investigator Site-Based Management, 115A BEHAVIORAL ASSESSMENTS Telephone Log Survey: Needs, Usage, Behavioral Evaluation of Drugs: A and Proposed Uniform Method, Comparison of the Behavioral Effects 116A of Adinazolam and Lorazepam, 65 Time Management in the Research Center: Can We Handle This BIBLIOGRAPHY Protocol?, 116A Quality of Life Bibliography and Indexes: Training for Submission of Quality 1992 Update, 203 Laboratory Specimens, 117A Use of a Communication Tool to BRAIN RESUSCITATION Facilitate Clinical Trials in the Emergency Medicine Research in the Hospital Setting, 118A Prehospital Setting: Strategies of the J. Clin. Res. Pharmacoepidemiol. 7:257-259-266 (1993) Subject Index 261 Brain Resuscitation Clinical Trial, CONDUCT 104A Innovative Approaches to the Conduct of Large-Scale Controlled Clinical Trials, CANDIDA VAGINITIS 107A Candida Vaginitis: Signs and Symptoms Aid Women’s Self-Recognition, 17 CONFIDENTIALITY Confidentiality Issues, Results, and CASE REPORT FORMS Demographics in Reporting Research Keying Case Report Form Design to Subjects’ Laboratory Results, 47A Medical Behavior and Medical Documentation Practices, 42A CONTROLS, MATCHED Reducing Case Report Form Corrections A Microcomputer-Assisted Methodology Through Use of a Standardized Case for the Selection of Matched Controls in Report Form Analysis System, 114A a Multisite Case-Control Study, 100A Use of FAX Technology for In-House Monitoring of CRFs, 43A DATA ENTRY A New High Speed Monitoring and Data CIRCADIAN RHYTHM Entry System, 45 Circadian Rhythm of Erythropoietin in Humans, 99A DATABASES How to Develop a Relational Database to CLINICAL RESEARCH Expedite the Investigator Selection ASSOCIATES Process for Clinical Trials, 107A Entry-Level Clinical Research Associate Ongoing Database Creation, 110A Training Course, 105A Prevention is the Best Medicine: A Remote Entry to Integrated Clinical Proactive Approach to a Quality, Project Database: On-Line Reporting Analyzable Database, 113A of Clinical Trial Site Visit Information Remote Entry to Integrated Clinical by Clinical Research Associates, 5OA Project Database: On-Line Reporting Skills Assessment of Clinical Research of Clinical Trial Site Visit Information Associates (CRAs), 49 by Clinical Research Associates, 50A Use of Project-Specific Development Plans for CRA Training, 118A DIAGNOSIS, DEFINITIVE Candida Vaginitis: Signs and COMMUNICATION Symptoms Aid Women’s Self- Maximize Subject Enrollment, Minimize Recognition, 17 Time and Effort: Get the Fax, 109A The PF (Pitfalls) of B (Brevity), 77 DIRECT-FROM-PATIENT- Phone Tag: The People’s Sport for the INFORMATION 90s, 121 Direct-From-Patient-InformationsM Telephone Log Survey: Needs, Usage, (DFPI). A Unique Concept for Clinical and Proposed Uniform Method, 116A and Marketing Research, 102A Use of a Communication Tool to Facilitate Clinical Trials in the DOCUMENTATION, SOURCE Hospital Setting, 118A Source Documentation in the Form of Use of FAX Technology for In-House Protocol-Specific Clinic Visit Sheets, Monitoring of CRFs, 43A 115A COMMUNICATION SYSTEMS DOCUMENTATION, STUDY Establishing an Effective Communication How to Assist the Paper Flow in System for Decentralized Monitors, Conducting Clinical Research Studies, 106A SIA Subject Index J. Clin. Res. Pharmacoepidemiol. 7:257-259-266 (1993) DOCUMENTATION ERRORS A Comparison of U.S. and E.C. Investigator Reference Guide Study, Preclinical Requirements as Addressed 109A at the First International Conference on Harmonization (ICH1), 147 DRUG ABUSE FDA-E.C. Harmonization Effects in the Confidentiality Issues, Results, and Area of GMPs, 154 Demographics in Reporting Research Harmonization and Registration Subjects’ Laboratory Results, 47A Procedures Within the E.C.: A European Perspective, 139 DRUG INVENTORY The Impact of European Common Market Drug Inventory Utilizing Wordperfect Regulations on the World 5.1’s Table Feature, 44A Pharmaceutical Industry, 127 Impact of the E.C. Regulations on the DRUG SCREENING World Pharmaceutical Industry—A ‘False Positive’ Urine Screen for Opiates Japanese Perspective, 161 Following Consumption of Poppy Round Table Summary Discussion, 174 Seed Muffins, 106A United States Trade Perspectives on European Community Developments, EDUCATION/TRAINING 130 Associates of Clinical Pharmacology Continuing Education Curriculums, 87 EXPERIMENTAL DESIGN Entry-Level Clinical Research Associate PRINCIPLES Training Course, 105A Untangling a Safety Controversy: Pressor Lessons Learned From Coordinating a Effects of Phenylpropanolamine, 3 Pivotal Clinical Trial, 31 The PF (Pitfalls) of B (Brevity), 77 GLOBAL CLINICAL The Role of the Coordinating Center DEVELOPMENT Project Manager in a Multicenter Global Project Management: A Clinical Clinical Trial, 243 Research Organization Perspective, Use of Project-Specific Development 53A Plans for CRA Training, 118A GROUP PRACTICE ELDERLY Clinical Research in the Group Practice Design Considerations for Anti- Setting, 101A Hypertensive Trials in the Elderly, 49A Elderly Population in Sequestered HARMONIZATION Clinical Trials, 104A A Comparison of U.S. and E.C. Quality of Life in the Elderly Patient After Preclinical Requirements as Addressed Open Heart Surgery, 47A at the First International Conference on Harmonization (ICH1), 147 EMERGENCY MEDICINE FDA-E.C. Harmonization Effects in the Emergency Medicine Research in the Area of GMPs, 154 Prehospital Setting: Strategies of the Harmonization and Registration Brain Resuscitation Clinical Trial, Procedures Within the E.C.: A 104A European Perspective, 139 ERYTHROPOIETIN Round Table Summary Discussion, 174 Circadian Rhythm of Erythropoietin in Humans, 99A HEALTH-RELATED QUALITY OF LIFE MEASURES EUROPEAN COMMON MARKET Quality of Life Bibliography and Indexes: REGULATIONS 1992 Update, 203 J. Clin. Res. Pharmacoepidemiol. 7:257-259-266 (1993) Subject Index 263 HEPATITIS B INVESTIGATOR REFERENCE Confidentiality Issues, Results, and GUIDE Demographics in Reporting Research Investigator Reference Guide Study, Subjects’ Laboratory Results, 47A 109A HUMAN IMMUNODEFICIENCY INVESTIGATOR SELECTION VIRUS (HIV) How to Develop a Relational Database to Confidentiality Issues, Results, and Expedite the Investigator Selection Demographics in Reporting Research Process for Clinical Trials, 107A Subjects’ Laboratory Results, 47A Patient’s Perception of Financial Impact JAPAN of HIV Treatment, 111A Impact of the E.C. Regulations on the World Pharmaceutical Industry—A HYPERTENSION Japanese Perspective, 161 Design Considerations for Anti- Round Table Summary Discussion, 174 Hypertensive Trials in the Elderly, 49A LORAZEPAM Behavioral Evaluation of Drugs: A INDEXES Comparison of the Behavioral Effects Quality of Life Bibliography and Indexes: of Adinazolam and Lorazepam, 65 1992 Update, 203 MANAGEMENT INDUSTRY/RESEARCH Innovative Approaches to the Conduct of COLLABORATION Large-Scale Controlled Clinical Trials, Lessons Learned From Coordinating a 107A Pivotal Clinical Trial, 31 Phase IIIB Clinical Trials: A Management Strategy for the Nineties, 111A INFORMED CONSENT Practically Interfacing . . . The Clinical Comprehension and Recall of the Investigations Unit, 112A Informational Consent of the Informed The Role of the Coordinating Center Consent Document: An Evaluation of Project Manager in a Multicenter 168 Patients in a Controlled Clinical Clinical Trial, 243 Trial, 41A Readability of the Patients’ Informed MARKETING RESEARCH Consent: A Continuing Problem in Direct-From-Patient-InformationSM Clinical Trials, 54A (DFPI). A Unique Concept for Clinical and Marketing Research, 102A INITIALS The PF (Pitfalls) of B (Brevity), 77 MEDWatch Commentary, 181 INPATIENT STUDIES Introducing MEDWatch: A New Inpatient Pharmacokinetic Studies: Approach to Reporting Medication and Improving Safety, 108A Device Adverse Effects and Product Problems, 183 INTERIM ANALYSES A Paradigm for Interim Analyses in MONITORS Controlled Clinical Trials, 193 Establishing an Effective Communication System for Decentralized Monitors, INTERNAL MARKETS 106A United States Trade Perspectives on European Community Developments, MORPHINE SCREENING 130 ‘*False Positive’’ Urine Screen for Subject Index J. Clin. Res. Pharmacoepidemiol. 7:257—259-266 (1993) Opiates Following Consumption of and Investigator Site-Based Poppy Seed Muffins, 106A Management, 115A MULTICENTER STRATEGIES PATIENT PARTICIPATION Multicenter Trial Strategies: An Audio/ Why Do Patients Participate in Clinical Visual Approach to Augment Study Research?, 119A Personnel Training, 46A The Role of the Coordinating Center PATIENT SATISFACTION Project Manager in a Multicenter Patient Satisfaction with Participation in a Clinical Trial, 243 Clinical Trial, 48A NALMEFENE PERSONNEL TRAINING Reversal of Effects of Morphine by Multicenter Trial Strategies: An Audio/ Nalmefene, 25 Visual Approach to Augment Study Personnel Training, 46A NARCOSIS Reversal of Effects of Morphine by PHASE I/II DATA MANAGEMENT/ Nalmefene, 25 MAINTENANCE Computer-Automated QA for Phase I/II NEWSPAPER ADVERTISEMENTS Clinical Trials, 102A Why Do Patients Participate in Clinical Research?, 119A PHASE I IMPLEMENTATION How to Implement a Phase I Protocol, OPERATIONS 52A The Role of the Coordinating Center Project Manager in a Multicenter PHASES Clinical Trial, 243 The Role of the Coordinating Center Project Manager in a Multicenter OPIATE SCREENING Clinical Trial, 243 ‘*False Positive’ Urine Screen for Opiates Following Consumption of PHENYLPROPANOLAMINE Poppy Seed Muffins, 106A Untangling a Safety Controversy: Pressor Effects of Phenylpropanolamine, 3 OPIOID ANTAGONIST Reversal of Effects of Morphine by PHONE TAG Nalmefene, 25 Phone Tag: The People’s Sport for the 90s, 121 PAPERWORK How to Assist the Paper Flow in PHOTOAGING Conducting Clinical Research Studies, The Clinical Quantification of SIA Photoaging, 101A PARTICIPATION PRECLINICAL REQUIREMENTS Patient Satisfaction with Participation A Comparison of U.S. and E.C. in a Clinical Trial, 48A Preclinical Requirements as Addressed Why Do Patients Respond to at the First International Conference on Newspaper Advertisements for Harmonization (ICH1), 147 Clinical Trials?, 119A PROJECT MANAGER PATIENT COMPLIANCE The Role of the Coordinating Center Techniques for Ensuring Patient Project Manager in a Multicenter Compliance Through Study Design Clinical Trial, 243 J. Clin. Res. Pharmacoepidemiol. 7:257—259-266 (1993) Subject Index 265 QUALITY Untangling a Safety Controversy: Pressor Training for Submission of Quality Effects of Phenylpropanolamine, 3 Laboratory Specimens, 117A SELF-RECOGNITION QUALITY IMPROVEMENT Candida Vaginitis: Signs and Symptoms PROCESS Aid Women’s Self-Recognition, 17 Integration of a Continuous Quality Improvement Process at an SKIN LESIONS Investigative Site, 54A The Clinical Quantification of Photoaging, 101A QUALITY OF LIFE Behavioral Evaluation of Drugs: A SKIN TESTING Comparison of the Behavioral Effects Skin Test Documentation: A Tape of Adinazolam and Lorazepam, 65 Transfer Method, 114A Quality of Life Bibliography and Indexes: 1992 Update, 203 STANDARD OPERATING Quality of Life in the Elderly Patient After PROCEDURES Open Heart Surgery, 47A Quality Assurance and the Implementation of SOPs During REGISTRATION Clinical Trials, 113A Harmonization and Registration Procedures Within the E.C.: A SWAT PROJECT MANAGEMENT European Perspective, 139 Organizational Challenges in SWAT Project Management, 43A REGULATORY AGENCIES Commentary, 181 TECHNOLOGY FDA-E.C. Harmonization Effects in the A New High Speed Monitoring and Data Area of GMPs, 154 Entry System, 45 Harmonization and Registration Drug Inventory Utilizing Wordperfect Procedures Within the E.C.: A 5.1’s Table Feature, 44A European Perspective, 139 Maximize Subject Enrollment, Impact of the E.C. Regulations on the Minimize Time and Effort: Get the World Pharmaceutical Industry—A Fax, 109A Japanese Perspective, 161 Use of FAX Technology for In-House Introducing MEDWatch: A New Monitoring of CRFs, 43A Approach to Reporting Medication and Device Adverse Effects and Product TELEPHONE LOG Problems, 183 Telephone Log Survey: Needs, Usage, Round Table Summary Discussion, 174 and Proposed Uniform Method, United States Trade Perspectives on 116A European Community Developments, 130 THROMBOLYSIS Does Entry into Thrombolysis Trials REGULATORY DECISION- Adversely Affect Time-to-Treatment? MAKING A Pilot Comparison in an Unblinded, Behavioral Evaluation of Drugs: A Non-randomized, Parallel Group Study Comparison of the Behavioral Effects and Nonstudy Patients, 103A of Adinazolam and Lorazepam, 65 TIME MANAGEMENT SAFETY Time Management in the Research Inpatient Pharmacokinetic Studies: Center: Can We Handle This Improving Safety, 108A Protocol?, 116A Subject Index J.Clin. Res. Pharmacoepidemiol. 7:257-259-266 (1993) TRIP REPORT FORMAT Reversal of Effects of Morphine by A Standardized Format for On- Nalmefene, 25 Site Monitoring Trip Reports, 52A WASTE MANAGEMENT Handling Waste in the Clinical Research TUBAL LIGATION Setting, 46A