II. Name the key-words that help you to catch the main idea of the text.

Lesson 10

Read the text: Theoretical basis for document and information activity (Part II)

The office prepares and maintains records and documents associated with its oversight of research and the administration of the boards.

These materials include, but are not limited to:

• Individual protocol records - IRB/OHRPP applications and supporting documentation

• Records of continuing review and amendment activities

• Copies of all official correspondence between the IRB and the investigators and key personnel

• Copies of the minutes of all IRB meetings.

• Rosters of the current IRB members and their qualifications

• Documentation of agreements to serve as IRB of record, or to rely upon external IRBs

• OHRPP/IRB policies and procedures

See the sections below for details.

Documentation for projects reviewed and approved by the UCLA IRB using webIRB are stored within webIRB.

Documentation for projects reviewed and approved by the UCLA IRB prior to implementation of webIRB are stored in a secure offsite storage facility (including copies of protocol documentation and IRB review communications) and in electronic records in the OHRPP office (including meeting minutes).

Investigators and research staff submit research applications (initial, continuing, amendment, and post-approval reports) requiring UCLA IRB/OHRPP review via the online, web-based webIRB application. webIRB is used to complete exempt, expedited, and full committee reviews of research involving human participants. 

IRB reviews, OHRPP staff communications of the results of IRB reviews, and investigators responses to the IRB requests are all completed online via webIRB. webIRB stores all correspondence between the study team and the IRB and serves as an electronic filing system for all study documentation.

Individual Protocol Records

The IRB prepares and maintains documentation of IRB activities for each protocol under review. Each protocol is assigned a unique number and documentation is maintained in a separate file. The IRB records are organized to allow reconstruction of a complete history of all IRB actions related to the review and approval of the protocol and clearly indicate what the IRB actually approved.

Records for each protocol will include the following (as applicable):

• All materials as described in Materials Required for IRB Review.

• Documentation resulting from any reviews by the exempt or expedited procedure.

• Copies of all correspondence between the IRB and the investigators and key personnel, including substantive email communications.

• Copies of study-related correspondence between the IRB and other entities, including regulatory authorities, other review committees and study subjects.

• Any additional documents deemed appropriate on a case-by-case basis.

Minutes

IRB staff will prepare minutes that document the proceedings of each convened IRB meeting. The Board’s correspondence to investigators, outlining the basis for requiring changes in or disapproving the research, is included in the minutes, making the IRB correspondence an official part of the minutes.

The minutes of IRB meetings will be written in sufficient detail to show:

• Attendance at the meeting including when an alternate member replaces a primary board member

• The names of IRB members who leave the meeting because of a conflict of interest for the study being discussed or for other reasons but need not be specified

• Attendance for each action including verification that quorum was met and maintained throughout the meeting (majority and nonscientist present)

• For each protocol reviewed, any votes or other actions taken and the vote on that action (including number of members voting for, against, or abstaining, and the names of any abstaining members)

• Verification and summary showing the IRB considered and found all required determinations (45 CFR 46.111) for protocol and informed consent approvals

• The basis for requiring changes in or disapproving research

• A written summary of controversial issues and their resolution

• For initial and continuing review, the approval period

• Summary of any continuing education provided to board members

• Documentation that the IRB was informed of all expedited review activity since the last IRB meeting

The sections of the webIRB application that include protocol-specific information supporting any waiver of informed consent or documentation of consentor the inclusion IRB Documentation of Activities will be identified in the minutes. If the Board disagrees with any of the protocol-specific information in the application, that will be documented in the “Committee Discussion” section of the minutes.

Six months to one year following official closure of a protocol, whether the IRB or investigator initiates the closure, webIRB records will be archived and may be retained indefinitely. Paper records, if any, for the protocol will be shipped to a secure off-site storage facility and may be retained indefinitely.

Document management is the process of handling documents in such a way that information can be created, shared, organized and stored efficiently and appropriately.

For many businesses, the focus of document management is on the organization and storage of documents. They want to be able to store documents in an organized and secure way that still allows documents to be found easily.

There is a move within large organizations to use document management software to help them do this. This may or may not involve using a document imaging system. While document management software is designed to make handling electronic files more efficient, it doesn’t let you convert paper files into electronic files like document imaging systems do.

The trend towards a paperless office is more realistic for some businesses than for others. Most businesses still operate in a “mixed” environment of paper and electronic data, so their document management system has to expedite the handling of paper documents as well.

It’s entirely possible for a business to create and use a document management plan that does not involve using either document management software or a document imaging system and such a plan may be the most appropriate choice for small businesses.

I. Answer the questions:

1. Who prepares and maintains records and documents?

2. What do Investigators and research staff submit?

3. What will records for each protocol include?

4. In what period of time will webIRB records be archived?

5. Why is the trend towards a paperless office realistic?

II. Pick out the basic information of every paragraph.

Lesson 11