[et_pb_section fb_built=”1″ _builder_version=”3.29.3″ background_color=”#c2efd7″ custom_padding=”31px||9px|||” border_color_bottom=”#7ebec5″ global_colors_info=”{}”][et_pb_row _builder_version=”3.29.3″ global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.29.3″ global_colors_info=”{}”][et_pb_text _builder_version=”4.11.1″ header_font=”Times New Roman||||||||” header_text_align=”center” header_font_size=”50px” header_letter_spacing=”2px” hover_enabled=”0″ global_colors_info=”{}” header_font_size_last_edited=”on|phone” sticky_enabled=”0″ header_font_size_phone=”25px”]

Institutional Review Board

[/et_pb_text][et_pb_divider divider_weight=”5px” _builder_version=”3.29.3″ global_colors_info=”{}”][/et_pb_divider][/et_pb_column][/et_pb_row][/et_pb_section][et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”3.29.3″ background_color=”#c2efd7″ global_colors_info=”{}”][et_pb_fullwidth_menu menu_id=”11″ active_link_color=”#0c71c3″ _builder_version=”3.29.3″ background_enable_color=”off” border_width_bottom=”2px” border_color_bottom=”#7ebec5″ global_colors_info=”{}”][/et_pb_fullwidth_menu][/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.29.3″ custom_padding=”2px|||||” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ _builder_version=”3.29.3″ custom_padding=”40px|||||” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”3.29.3″ global_colors_info=”{}”][et_pb_text _builder_version=”3.29.3″ header_font_size=”19px” custom_margin=”||1px|||” custom_padding=”0px||23px|||” link_option_url=”/wp-content/uploads/2021/05/POLICY-IRB-02-rev-1.pdf” link_option_url_new_window=”on” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

POLICY ON THE CONDUCT OF RESEARCH

“]

POLICY ON THE CONDUCT OF RESEARCH

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ header_font_size=”20px” custom_margin=”1px||1px|||” global_colors_info=”{}”]

SOP Chapter 1

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/1.1-Appointment-of-IRB-Members.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|desktop” content__hover=”

1.1 Appointment of IRB Members

“]

1.1 Appointment of IRB Members

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/1.2-Appointment-of-Independent-Consultants.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

1.2 Appointment of Independent Consultants

“]

1.2 Appointment of Independent Consultants

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/1.3-Training-of-IRB-Members-and-Staff.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|desktop” content__hover=”

1.3 Training of IRB Members and Staff

“]

1.3 Training of IRB Members and Staff

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ header_font_size=”20px” custom_margin=”||1px|||” custom_padding=”30px|||||” global_colors_info=”{}”]

SOP Chapter 2

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/2.1-Management-of-Initial-Protocol-Submissions.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

2.1 Management of Initial Protocol Submissions

“]

2.1 Management of Initial Protocol Submissions

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/2.2-Use-of-Study-Assessment-Forms.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

2.2 Use of Study Assessment Forms

“]

2.2 Use of Study Assessment Forms

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/2.3-Exempt-from-Review.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

2.3 Exempt from Review

“]

2.3 Exempt from Review

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/2.4-Expedited-Review.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

2.4 Expedited Review

“]

2.4 Expedited Review

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/2.5-Full-Board-Review-of-Submitted-Protocols.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

2.5 Full Board Review of Submitted Protocols

“]

2.5 Full Board Review of Submitted Protocols

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/2.6-Review-of-Resubmission.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

2.6 Review of Resubmission

“]

2.6 Review of Resubmission

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ header_font_size=”20px” custom_margin=”||1px|||” custom_padding=”30px|||||” global_colors_info=”{}”]

SOP Chapter 3

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/3.1-Review-of-Protocol-Amendment.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

3.1 Review of Protocol Amendment

“]

3.1 Review of Protocol Amendment

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/3.2-Review-of-Progress-Report.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

3.2 Review of Progress Report

“]

3.2 Review of Progress Report

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/3.3-Review-of-Final-Report.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

3.3 Review of Final Report

“]

3.3 Review of Final Report

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/3.4-Review-of-Serious-Adverse-Event.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

3.4 Review of Serious Adverse Event

“]

3.4 Review of Serious Adverse Event

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/3.5-Review-of-Protocol-Violation-Deviation.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

3.5 Review of Protocol Violation Deviation

“]

3.5 Review of Protocol Violation Deviation

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/3.6-Continuting-Review.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

3.6 Continuting Review

“]

3.6 Continuting Review

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/3.7-Responding-to-Participants-Request-Query.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

3.7 Responding to Participants Request Query

“]

3.7 Responding to Participants Request Query

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/3.8-Site-Visits.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

3.8 Site Visits

“]

3.8 Site Visits

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/3.9-Review-of-Early-Protocol-Termination.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

3.9 Review of Early Protocol Termination

“]

3.9 Review of Early Protocol Termination

[/et_pb_text][/et_pb_column][et_pb_column type=”1_2″ _builder_version=”3.29.3″ global_colors_info=”{}”][et_pb_text _builder_version=”3.29.3″ header_font_size=”20px” custom_margin=”||1px|||” global_colors_info=”{}”]

SOP Chapter 4

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/4.1-Preparation-of-Meeting-Agenda.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

4.1 Preparation of Meeting Agenda

“]

4.1 Preparation of Meeting Agenda

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/4.2-Conduct-of-a-Full-Board-Meeting.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

4.2 Conduct of a Full Board Meeting

“]

4.2 Conduct of a Full Board Meeting

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/4.3-Preparation-of-Meeting-Minutes.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

4.3 Preparation of Meeting Minutes

“]

4.3 Preparation of Meeting Minutes

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/4.4-Communicating-IRB-Decision-to-PI.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

4.4 Communicating IRB Decision to PI

“]

4.4 Communicating IRB Decision to PI

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/4.5-Management-of-IRB-Communications.pdf” link_option_url_new_window=”on” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

4.5 Management of IRB Communications

“]

4.5 Management of IRB Communications

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/4.6-Management-of-Active-Study-Files.pdf” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

4.6 Management of Active Study Files

“]

4.6 Management of Active Study Files

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/4.7-Archiving-of-Inactive-Study-Files.pdf” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

4.7 Archiving of Inactive Study Files

“]

4.7 Archiving of Inactive Study Files

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/4.8-Maintenance-of-Confidentiality-of-Study-Files-and-IRB-Documents.pdf” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

4.8 Maintenance of Confidentiality of Study Files and IRB Documents

“]

4.8 Maintenance of Confidentiality of Study Files and IRB Documents

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ header_font_size=”20px” custom_margin=”||1px|||” custom_padding=”30px|||||” global_colors_info=”{}”]

SOP Chapter 5

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/5.1-Writing-SOPs.pdf” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

5.1 Writing SOPs

“]

5.1 Writing SOPs

[/et_pb_text][et_pb_text _builder_version=”3.29.3″ text_font=”|600|||||||” text_text_color=”#000000″ text_font_size=”17px” custom_margin=”-1px||3px|||” custom_padding=”2px|||35px||” link_option_url=”/wp-content/uploads/2021/05/5.2-Revising-SOPs.pdf” text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” content__hover_enabled=”on|hover” content__hover=”

5.2 Revising SOPs

“]

5.2 Revising SOPs

[/et_pb_text][/et_pb_column][/et_pb_row][/et_pb_section]