OM t of c.iii - Vision Research Coordinating Center - Washington ...

More documents

Recommendations

Info

2/22/96 Chapter 15 Coordinating Center page 15-10 datasets (a SAS library) resides on a single shared-use disk on a Biostatistics server. Monthly “snapshot” copies of the data library are made for the production of those management reports which the Executive Committee, the Coordinating Center, and the Data Monitoring and Oversight Committee jointly develop. Other programs extract analysis subsets for interim analyses and quality control monitoring. This freezing of the dataset allows for more consistent analyses than continually making the analytic runs from a live database which is constantly changing as new forms are added and corrections are made. As appropriate, only forms which have passed all edit checks are included in analyses. Forms are entered and initially edited at the Clinic, transmitted, received and re-edited at the Coordinating Center. Attached to each observation are flags indicating the stage of processing for that form. Along with these flags are the relevant dates so that aged management reports can track forms flow. 15.9 Dataset Backup Daily archives of the library are made with weekly backups stored off-site as protection against disaster. 15.9.1 Data Security As the central repository of information for the study, the Coordinating Center has particular responsibilities towards the security of the data. The Coordinating Center protects the data from all hazards including disasters and unauthorized access. The computer room in the Division of Biostatistics is locked to access except by staff and contains fire and heat sensors which are connected to alarms at the guard's desk located about 30 feet away. The computer system is backed up for file integrity purposes weekly, and the monthly backups are stored in a remote facility. The data for this study are also separately backed up and stored in a safety deposit vault at a nearby bank. Additional security in the form of an electronic card-access system is being installed in 1995. To guard against unauthorized access to the data, all shared use computer systems are protected with passwords which are changed frequently. Only individuals with a particular “need to know” are given access and system privileges are carefully restricted. All of the PCs to be used in the Coordinating Center are located within a secure area and the area is locked when not in use. SAS itself supports passwords for its data sets which makes it more difficult to access information in an intelligible fashion. Each participating staff member requiring access to study datasets receives a password with an associated “security level.” Those whose need-to-know is limited to reports will have the lowest access privileges, “reports only.” Those who need to review information on a patient-by-patient basis receive “BROWSE” privileges. Individuals performing data entry and editing have “ENTRY” privilege. And a single person at
2/22/96 Chapter 15 Coordinating Center page 15-11 each site has “supervisory” privileges, including the ability to change the passwords for other staff members. Systems connected to the ethernet are carefully controlled and all systems without ethernet access control (e.g. PCs) are insulated from the backbone by bridges or routers. The ethernet cable itself is routed only through secure passageways. 15.10 Electronic Mail Electronic mail facilitates communications among the various components of the study, provides a record of interactions, facilitating the documentation of decisions affecting the study, encourages the distribution of information exchanged between individuals to all those who should be kept abreast of the discussion. E-mail is often more efficient than telephone calls because it allows for the work to be scheduled into the workload of the Clinic rather than being an unscheduled disruption at the convenience of the Coordinating Center. In order to support the use of electronic mail among CLEK Study sites, a very early task is to survey each of the participants to ascertain their current utilization of e- mail. Our previous experience leads us to believe that much greater acceptance of the use of e-mail is obtained when a user needs to know only a single system and has local support for the use of that mail system. Washington University is well situated on both BITNET and the Internet (NSFNET) so most probably, mechanisms already exist for transferring mail from a particular site to the Coordinating Center and to other Study participants. If the particular Study participant does not use e-mail, but their institution does provide well supported e-mail services on one of the academic networks, then we will work with the user to obtain services from that institution. 15.11 References Achtenberg J, Casanova P: A hematology laboratory system using SAS(r)PC. Proceedings of the 14th Annual SAS User's Group International Conference, SAS Institute, Cary, 1472-1478, 1989. Anderson PK and Gill RD: Cox regression models for counting processes: a large sample study. Annals of Statistics. 10:1100-1120, 1982. Fleming TR and Harrington DP: Counting Processes and Survival Analyses. John Wiley & Sons, New York, 1991. Fleming TR, Harrington DP, and O’Brien PC: Designs for group sequential tests. Controlled Clinical Trials 5:348-361, 1984. Glynn RJ and Rosner B: Accounting for the correlation between fellow eyes in regression analysis. Arch Ophthalmology 110:381-387, 1992. Kaplan EL and Meier P: Nonparametric estimation from incomplete observations. JASA. 53: 457-481, 1958. Lan KK and DeMets DL: Discrete sequential boundaries for clinical trials. Biometrika 70:659-663, 1983.
Page 1 and 2:
2/22/96 CLEK OM Table of Contents p
Page 3 and 4:
Page 5 and 6:
Page 7 and 8:
2/1/99 CLEK OM Table of Contents pa
Page 9 and 10:
2/1/99 Chapter 1 Background page 1-
Page 11 and 12:
Page 13 and 14:
Page 15 and 16:
Page 17 and 18:
Page 19 and 20:
Page 21 and 22:
Page 23 and 24:
Page 25 and 26:
Page 27 and 28:
Page 29 and 30:
Page 31 and 32:
Page 33 and 34:
2/1/99 Chapter 2 Study Design page
Page 35 and 36:
Page 37 and 38:
Page 39 and 40:
Page 41 and 42:
Page 43 and 44:
Page 45 and 46:
Page 47 and 48:
Page 49 and 50:
Page 51 and 52:
Page 53 and 54:
Page 55 and 56:
2/22/96 Chapter 3 Entry and Enrollm
Page 57 and 58:
2/22/96 Chapter 3 Entry and Enrollm
Page 59 and 60:
2/1/99 Chapter 4 Recruitment, Educa
Page 61 and 62:
Page 63 and 64:
Page 65 and 66:
Page 67 and 68:
2/1/99 Chapter 5 Scheduling page 5-
Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
Page 75 and 76:
2/22/96 Chapter 6 Vision Assessment
Page 77 and 78:
Page 79 and 80:
Page 81 and 82:
Page 83 and 84:
2/22/96 Chapter 7 Slit Lamp, Fundus
Page 85 and 86:
Page 87 and 88:
Page 89 and 90:
1/1/2005 Chapter 8 Corneal Curvatur
Page 91 and 92:
Page 93 and 94:
Page 95 and 96:
Page 97 and 98:
Page 99 and 100:
Page 101 and 102:
Page 103 and 104:
Page 105 and 106:
Page 107 and 108:
Page 109 and 110:
Page 111 and 112:
Page 113 and 114: 1/1/2005 Chapter 8 Corneal Curvatur
Page 115 and 116: 1/1/2005 Chapter 8 Corneal Curvatur
Page 117 and 118: 2/22/96 Chapter 9 Contact Lens Fit
Page 125 and 126: 2/22/96 Chapter 10 Fluorescein Phot
Page 127 and 128: 2/22/96 Chapter 10 Fluorescein Phot
Page 129 and 130: 2/22/96 Chapter 11 Corneal Photogra
Page 135 and 136: 2/22/96 Chapter 12 Certification pa
Page 143 and 144: 2/2/99 Chapter 13 Chairman and Clin
Page 149 and 150: 2/1/99 Chapter 14 CPRC page 14-2 Fi
Page 151 and 152: 2/1/99 Chapter 14 CPRC page 14-4 Th
Page 153 and 154: 2/1/99 Chapter 14 CPRC page 14-6 Pr
Page 155 and 156: 2/22/96 Chapter 15 Coordinating Cen
Page 163: 2/22/96 Chapter 15 Coordinating Cen
Page 169 and 170: 2/22/96 Study Organization page 16-
show all

OM t of c.iii - Vision Research Coordinating Center - Washington ...

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?