PARTNERS HUMAN RESEARCH QUALITY IMPROVEMENT PROGRAM GUIDANCE FOR CLINICAL RESEARCH SOP WRITING

PURPOSE The purpose of this guidance is to assist principal investigators and study staff with the writing and development of their own standard operating procedures (SOPs). The recommended process/format should be followed:

DEPARTMENT (specify department, institution) STANDARD OPERATING PROCEDURE

Version #: _______ Effective Date: ________

I.

Standard Operating Procedure For Writing SOPs

1.0 1.1 1.# Purpose/Scope: This procedure descri es the standard format and method for esta !ishin" standard operatin" procedures at this investi"ationa! site. This procedure is intended to meet $D% federa! re"u!ations (#1 &$' (0, (), *1#, *1+, )00, ,1#) as -e!! as .ood &!inica! /ractice .uide!ines. Respo s!"!#!$!es: The c!inica! research staff is responsi !e for preparin" and comp!yin" -ith 01/s at this site. Proce%ures: 2ritin" the 01/: *.1.1 %fter identifyin" need for 01/, the author decides on the !eve! of detai! for the 01/.

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The author prepares a step y step tas3 !ist of the activity inc!udin" -ho is responsi !e for each activity. Each activity is eva!uated for efficiency, effectiveness, and comp!iance -ith $D% re"u!ations, "uide!ines and institutiona! po!icy. Too!s are desi"ned and (attached -here app!ica !e) to e used -ith the 01/ such as forms, temp!ates, !o"s, chec3!ists, etc. The first draft of 01/ is comp!eted. Each 01/ is revie-ed (include by who) for accuracy and feasi i!ity. %!! comments and revisions are eva!uated and are inc!uded in the fina! version as appropriate. The fina! version (including version dates) is comp!eted and distri uted to c!inica! research staff.

01/ &over /a"e: 5nc!ude 01/ version num er, u!!etin, scope, effective date and tit!e of 01/. Tit!e of 01/: 5nc!ude a tit!e that is descriptive ut not too !on". 6u!!etin: 5nc!ude imp!ementation p!an and revision history 0cope: 5nc!ude audience to -hom the 01/ app!ies.

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/urpose of 01/: 5nc!ude the o 7ective of the 01/. 'esponsi i!ities: 5nc!ude -ho is responsi !e for oversi"ht of the 01/, performin" the activities, or other procedure responsi i!ities. /rocedures: 5nc!udes the tas3s or step y step procedures necessary to comp!ete the activity. 5nc!ude definitions as necessary. 'e"u!ations and .uide!ines: 8ist app!ica !e re"u!ations and "uide!ines (e.". 5&9 .&/, /9'&) 'eference: 8ist app!ica !e references used in the creation of the 01/. :ay inc!ude other 01/ re!ated to current 01/

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Definitions;%cronyms: 5nc!ude 3ey terms used in 01/ %ttachments %ttach forms, chec3!ists, f!o-charts, or other additiona! information that supp!ements the procedura! activities descri ed in 01/. 5mp!ementation: +.1.1 +.1.# %fter the 01/ is fina!i=ed, the author distri utes copies to a!! c!inica! research staff. %s each 01/ is imp!emented, a trainin" session is conducted to ensure that a!! study staff understands the re>uirements of the 01/ and each person can comp!ete their responsi i!ities as desi"nated in the 01/. Documentation of the trainin" session is maintained in the personne! trainin" record. /rincipa! 5nvesti"ator supports the 01/ and the re>uired tas3s are to e performed at this site.

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01/ revisions: (.1.1 (.1.# (.1.* (.1.+ Each 01/ is revie-ed annua!!y. 'evisions are made accordin"!y to account for chan"es in re"u!ation, site procedure or institutiona! po!icy. 'evisions are !a e!ed as such -ith an effective date and a ne- version date. % copy of the revised 01/ is sent to each staff mem er -ho is instructed to destroy the previous version of the 01/. %!! previous versions of the 01/ are 3ept on fi!e in room # 1?#*.

Re&ere ces: /artners @5 /ro"ram 'oundta !e /resentation: 0tandard 1peratin" /rocedures A 2here to 0tartB A /resenters: 0tan!ey Estime and Cu!ie Da erry