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  • Version 3.0 February 23, 2007

    AGE-RELATED EYE DISEASE STUDY 2 MANUAL OF PROCEDURES

    Age-Related Eye Disease Study 2 (AREDS2): A Multi-center, Randomized Trial of Lutein, Zeaxanthin, and Omega-3 Long-Chain Polyunsaturated Fatty Acids (Docosahexaenoic Acid [DHA] and Eicosapentaenoic Acid [EPA]) in Age-Related Macular Degeneration

    IND # 74,781

    Study Chair: Emily Chew, MD National Eye Institute (NEI) Division of Epidemiology and Clinical Research Clinical Trials Branch Bldg. 10, CRC, 3-2531 10 Center Drive, MSC 1204 Bethesda, MD 20892-1204 Tel: 301-496-6583 Fax: 301-496-7295 E-mail: echew@nei.nih.gov Coordinating Center: The EMMES Corporation 401 N. Washington Street, Suite 700 Rockville, MD 20850-1785 Tel: 866-375-9924 Fax: 877-804-9618 E-mail: areds2@emmes.com Medical Monitor: Robert W. Lindblad, MD Chief Medical Officer The EMMES Corporation 401 N. Washington Street, Suite 700 Rockville, MD 20850-1785 Tel: 301-251-1161 Fax: 301-251-1355 E-mail: rlindblad@emmes.com This study is being conducted in compliance with the protocol, FDA regulations (21 CFR Parts 50, 54, and 56, 312), Good Clinical Practices, applicable local regulations, and the Declaration of Helsinki.

    mailto:echew@nei.nih.govmailto:areds2@emmes.commailto:rlindblad@emmes.com

  • AREDS2 MOP

    Version 3.0 February 23, 2007

    TABLE OF CONTENTS

    1. STUDY OVERVIEW................................................................................................ 1 2. STUDY ORGANIZATION........................................................................................ 2

    2.1. Introduction ................................................................................................ 2 2.2. NEI Study Chairs Office ............................................................................ 2 2.3. Clinical Centers.......................................................................................... 3 2.4. Coordinating Center................................................................................... 4 2.5. Fundus Photograph Reading Center ......................................................... 5 2.6. National Eye Institute (NEI)........................................................................ 6 2.7. National Institutes of Health Research Contracts ...................................... 6 2.8. Pharmaceutical Company.......................................................................... 6 2.9. Drug Distribution Center ............................................................................ 6 2.10. Central Laboratory (Interagency Agreement)............................................. 7 2.11. Nutrition Coordinating Center (Subcontract with Coordinating Center)...... 7 2.12. NEI Project Team ...................................................................................... 7 2.13. Data and Safety Monitoring Committee ..................................................... 7 2.14. Operations Committee............................................................................... 8 2.15. Executive Committee................................................................................. 8 2.16. Technical Group ........................................................................................ 9 2.17. Coordinators Group................................................................................. 10 2.18. Training and Certification Committee....................................................... 10 2.19. Analysis Planning Committee .................................................................. 11 2.20. Other Committees.................................................................................... 11

    3. STUDY POLICIES ................................................................................................ 15 3.1. Introduction .............................................................................................. 15 3.2. Informed Consent .................................................................................... 15 3.3. Protection of Human Subjects ................................................................. 15 3.4. Publicity ................................................................................................... 16 3.5. Disclosure of Study Results ..................................................................... 16 3.6. Scientific Publications and Presentations ................................................ 16

    3.6.1. Generation of Publications and Presentations .............................. 16 3.6.2. Editorial Review ............................................................................ 17 3.6.3. Authorship..................................................................................... 17 3.6.4. Acknowledgements ....................................................................... 18

    3.7. Ancillary and Parallel Studies .................................................................. 18 3.7.1. Definitions ..................................................................................... 18

    3.7.1.1. Ancillary studies............................................................. 18 3.7.1.2. Parallel studies .............................................................. 19

    3.7.2. Approval of Ancillary and Parallel Studies..................................... 19 3.7.2.1. Studies conducted by AREDS2 investigators. ............... 19

    3.7.3. Funding and Publication of Ancillary and Parallel Studies ............ 20 3.7.3.1. Funding.......................................................................... 20 3.7.3.2. Publication ..................................................................... 21

  • AREDS2 MOP

    Version 3.0 February 23, 2007

    3.8. Adverse Experience Reporting ................................................................ 21 3.8.1. Definition of the Adverse Experience ............................................ 21 3.8.2. Adverse Experience Reporting and Management......................... 22

    4. EXAMINATION SCHEDULE ................................................................................. 23 4.1. Overview of Schedule and Description of Participant Visits..................... 23 4.2. Qualification ............................................................................................. 23

    4.2.1. Qualification Visit........................................................................... 23 4.2.2. Requalification Visit....................................................................... 26

    4.3. Randomization Visit ................................................................................. 26 4.4. Follow-Up Visits ....................................................................................... 28

    4.4.1. Telephone Contact........................................................................ 29 4.4.2. In Clinic/Annual Visits.................................................................... 29

    4.5. Missed Visits and Inactive Participants .................................................... 29 4.6. Hospitalization Discharge Summaries/Death Reports ............................. 30

    5. EXAMINATION PROCEDURES ........................................................................... 32 5.1. Dilated Fundus Examination .................................................................... 32 5.2. Refraction and Visual Acuity Measurements ........................................... 32 5.3. Fundus Photography ............................................................................... 32 5.4. Adverse Event Reporting Procedures...................................................... 33 5.5. Procedures for Non-AREDS2 Participant Visits....................................... 33

    5.5.1. Participants Relocating Away from the Clinical Center ................. 33 5.5.2. Home Visits ................................................................................... 34

    5.6. End-of-Trial Clinic/Home Visit Guidelines ................................................ 34 5.6.1. Clinic Visits.................................................................................... 34 5.6.2. Home Visits ................................................................................... 35

    6. CERTIFICATION PROCEDURES ........................................................................ 36 6.1. Introduction .............................................................................................. 36

    6.1.1. Activities Requiring Certification.................................................... 36 6.1.2. Obtaining and Maintaining Certification......................................... 36 6.1.3. Decertification ............................................................................... 37

    6.2. Certification for Refraction and Visual Acuity ........................................... 37 6.3. Certification for Photography ................................................................... 37 6.4. Certification for Nutritional Biochemistry Study ........................................ 39 6.5. Certification for the AdvantageEDCSM Production System....................... 40

    6.5.1. Users Training Practicum.............................................................. 40 6.6. Certification for Cognitive Function Telephone Battery............................ 40 6.7. Examination by Non-Certified Personnel ................................................. 40 6.8. Food Frequency Questionnaire Techniques ............................................ 41

    7. DESCRIPTION OF INTERVENTION .................................................................... 44 7.1. Introduction ...................................