Microsoft Word search phase 3 Title Page Amendment

Tracking and Reporting of Study Data 
The tracking of data collection through the study is implemented using a web-based 
interface.  Checks are run to see that any expected data has arrived within the specific 
window of time allotted for that data.  Automated reports list delinquent data items which 
are maintained online.  Some missing data elements are emailed automatically to study 
centers.  In addition, a variety of online reports are constructed for use by the study 
centers, the CoC, and possibly CDC and NIDDK in order to monitor study progress and 
protocol compliance.  These reports differ in content depending on the requirements of 
the individual user, and access is restricted to persons with the appropriate security 
clearance.  Automated reports are developed that circulate this information to the 
appropriate places (e.g., PI, IRBs, etc.).  Security reports are available to monitor 
authorized and unauthorized attempts to access portions of the system. 
7.3.8.
 
Data Conversion and Extraction 
SAS analysis files are extracted from the database using SAS/Access.  Programmers 
develop routines to create other specialized analysis files from the SQL Server database 
or the SAS database.  Prior to merging or extracting any data into or from the database, 
merge/extraction routines are developed and thoroughly tested.  All testing is documented 
in study logs.  Since data arrives from differing locations, verification includes 
consistency checks across all platforms as well as any other routine checks.  All routines 
are properly documented and changes and updates to the code are noted. 
7.3.9.
 
Database Closure and Documentation 
Upon study completion, after all clinic and laboratory data have been collected and 
filtered through various QC routines, the resulting SQL Server database will be converted 
to SAS and ASCII data sets and certified.  The database will be taken offline and 
archived on magnetic tape and/or CDROM.  The final data sets will be certified and 
issued version numbers to synchronize analytic efforts.  They will then be distributed in 
accordance with SC and institutional policy.  The choice of media and database copy 
distribution method to the investigators will depend upon the systems and media 
available. 

---

Section 7 - Data Management (Phase 3 - 12/2010) 
Section 7 - Page 6 
 
Documentation will be prepared that contains a brief overview of the project, the goals, 
and the type of data collected.  This will be followed by a data dictionary, including a list 
of variable names, their positions, and short descriptions of each variable contained on 
the media.  Unique data transformations and clarifications will be provided.  The CoC 
will also create a plan for developing a distributed data set with SEARCH investigators.  
The CoC has appropriate HIPAA relationships with each of the SEARCH clinical 
centers. 
7.3.10.
 
Data Sharing 
SEARCH investigators understand the need to publicly share study research data in a 
timely fashion.  They also understand the need to maintain the confidentiality of the study 
participants.  The procedures for data sharing ensure that: 1) confidential information is 
not disclosed; 2) data are released in a form that does not endanger national security or 
compromise law enforcement activities; and that 3) proprietary data (i.e., data owned by 
private organizations such as Managed Care Organizations, Preferred Provider 
Organizations, or technology firms) are not released inadvertently. 
The final study analytical database will be processed in a timely fashion for public data 
sharing.  During this process we will de-identify the participant data by using standard 
acceptable processes which include: removal of identifiers, translation of dates and ages 
to delta time values, assignment of random study identifiers and any other methods that 
are acceptable at that time.  Out of this process will be a series of de-identified data files 
representing the final analytical data set.  These data files will be provided in a standard 
format which is readable across a variety of applications and operating system platforms, 
such as Microsoft Excel for example.  Documentation that will be provided along with 
the data sharing file will include but not be limited to: data dictionary, data code book, 
valid variable ranges (where provided), the protocol, procedure and operational manuals, 
and any electronic versions of any paper forms that were used in data collection.  
Documentation will be provided in a standard format (such as Adobe Acrobat and Rich 
Text Format) that is readable on a variety of platforms.  Any requests for copies of the 
data sharing files and documentation will be provided by the Principal Investigator 
through an industry acceptable medium such as CD-ROM, DVD-ROM, web site 
download, or any other transfer medium that has wide support at that time.  
Data will be released to the funding agencies in a timely fashion.  The SEARCH Steering 
Committee will develop a plan for the sequential release of data during the study and will 
the release of the final dataset according to federal guidelines. 
Data will be transmitted electronically between the SEACH CoC and the Ocular 
Epidemiology Reading Center and the Central Laboratory.   

---

Section 7 - Data Management (Phase 3 - 12/2010) 
Section 7 - Page 7 
 
7.3.11.
 
Data Destruction 
7.3.11.1.
 
Data destruction guideline 
Only those records retained for a period of time greater than the applicable retention 
schedule may be disposed of in accordance with these guidelines.  PHI will be 
destroyed/disposed by using a method that ensures the PHI cannot be recovered or 
reconstructed.  EPHI will be done in the same fashion. 
7.3.11.2.
 
Retention period 
The Health Insurance Portability and Accountability Act Of 1996 requires that data 
be kept for a minimum of 6 years beyond the close of the study, or in compliance 
with local IRBs.  Therefore, all records must be maintained until that point.  The 
schedule for destruction/disposal shall be suspended for records involved in any open 
investigation, audit or litigation. 
7.3.11.3.
 
Destruction of paper records 
Paper records containing confidential information should be destroyed using a 
secured method and not depositing into standard trash receptacles. 
7.3.11.4.
 
Destruction of electronic records 
Deletion of the contents of digital files and emptying of the desktop "trash" or "waste 
basket" is the first step.  It must be kept in mind however, that reconstruction and 
restoration of "deleted" files is fairly easy for computer specialists to do "hard drive," 
using commercially available software applications.  When properly applied, these 
tools prevent the reconstruction of any data formerly stored on the hard drive.  Floppy 
disks, data stored on CD-ROM’s, or on back-up tapes should be physically destroyed.  
7.3.11.5.
 
Destruction records 
A destruction record is an inventory describing and documenting those records, in all 
formats, authorized for destruction, as well as the date, agent, and method of 
destruction.  The destruction record itself shall not contain confidential information. 
 

---

SEARCH Phase 3 Protocol - Section 8A 
Registry Study 
Human Subjects 
Table of Contents