{"id":3842,"date":"2017-04-28T16:16:19","date_gmt":"2017-04-28T14:16:19","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=3842"},"modified":"2025-05-21T10:45:55","modified_gmt":"2025-05-21T08:45:55","slug":"ecrire-de-super-procedures-operatoires-standardisees","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/ecrire-de-super-procedures-operatoires-standardisees\/","title":{"rendered":"Comment \u00e9crire de SUPER proc\u00e9dures op\u00e9ratoires standardis\u00e9es?"},"content":{"rendered":"

Article r\u00e9dig\u00e9 par la Soci\u00e9t\u00e9 Pharmaspecific, sp\u00e9cialiste en recherche clinique<\/i><\/span><\/p>\n

Bienvenue \u00e0 toi cher lecteur !<\/p>\n

Aujourd\u2019hui, nous allons t\u2019expliquer ce que sont les proc\u00e9dures op\u00e9ratoires standardis\u00e9es<\/strong> et comment bien les r\u00e9diger.<\/p>\n

Tu trouveras \u00e0 la fin de cet article un exemple de plan d\u2019une proc\u00e9dure<\/strong>.<\/p>\n

R\u00e9dig\u00e9 par H\u00e9di Selmi<\/strong><\/em><\/p>\n

<\/p>\n

Les proc\u00e9dures op\u00e9ratoires, qu\u2019est-ce que c\u2019est ?<\/strong><\/em><\/h2>\n

Une proc\u00e9dure op\u00e9ratoire standardis\u00e9e, c\u2019est un document<\/strong> qui d\u00e9crit comment r\u00e9aliser une activit\u00e9, selon les \u00ab normes \u00bb de l\u2019entreprise pour laquelle tu travailles.<\/p>\n

En d\u2019autres mots, ce document d\u00e9crit de mani\u00e8re chronologique les op\u00e9rations que le salari\u00e9 va devoir r\u00e9aliser<\/strong>, afin de mener \u00e0 bien une activit\u00e9 sp\u00e9cifique.<\/p>\n

On peut comparer les proc\u00e9dures, grossi\u00e8rement, \u00e0 une \u00ab recette de cuisine \u00bb : tu peux suivre chacune des \u00e9tapes et ainsi r\u00e9aliser une activit\u00e9 au sein de l\u2019entreprise.<\/p>\n

Par exemple :<\/em><\/p>\n

– Proc\u00e9dure pour r\u00e9aliser une visite de monitoring<\/em><\/p>\n

– Proc\u00e9dure de soumission r\u00e8glementaire au Comit\u00e9 de protection des personnes (CPP)<\/em><\/p>\n

Aller, maintenant que tu sais ce qu\u2019est une proc\u00e9dure op\u00e9ratoire standardis\u00e9e<\/a>, rentrons un peu plus dans le d\u00e9tail.<\/p>\n

\u00c0 quoi servent les proc\u00e9dures ?<\/strong><\/em><\/h2>\n

En g\u00e9n\u00e9ral, elles vont t\u2019aider \u00e0 r\u00e9aliser une t\u00e2che ou une activit\u00e9 en toute autonomie<\/strong>, lorsque tu as un doute sur certaines actions dans le cadre de ton travail ou que tu veux comprendre comment est r\u00e9alis\u00e9e une activit\u00e9 tu lis la proc\u00e9dure.<\/p>\n

Elles vont \u00e9galement servir \u00e0 former un nouvel arrivant<\/strong> dans l\u2019entreprise.<\/p>\n

Elles vont \u00e9galement permettre \u00e0 ton entreprise de fournir un \u00ab r\u00e9sultat constant \u00bb,<\/strong> car toutes les activit\u00e9s seront r\u00e9alis\u00e9es de la m\u00eame mani\u00e8re par chaque employ\u00e9. C\u2019est plut\u00f4t rassurant pour les clients.<\/p>\n

Ces proc\u00e9dures sont utiles aussi pour comprendre le fonctionnement d\u2019une activit\u00e9 complexe<\/strong> \u00e0 r\u00e9aliser.<\/p>\n

Qui r\u00e9dige les proc\u00e9dures ?<\/em><\/h2>\n

Tous les salari\u00e9s peuvent \u00eatre amen\u00e9s \u00e0 participer de la r\u00e9daction des proc\u00e9dures. C\u2019est int\u00e9ressant qu\u2019elles soient r\u00e9dig\u00e9es par les collaborateurs<\/strong> : ils sont les premiers concern\u00e9s par ces documents et peuvent donc les adapter aux mieux \u00e0 la r\u00e9alit\u00e9. De plus, cela va permettre de mieux comprendre le document.<\/p>\n

Il est n\u00e9cessaire que ces proc\u00e9dures soient relues par d\u2019autres collaborateurs<\/strong>, afin que chacun \u00ab apporte sa pierre \u00e0 l\u2019\u00e9difice \u00bb et apporte sa propre vision.<\/p>\n

Joindre l\u2019utile \u00e0 l\u2019agr\u00e9able !<\/em><\/h2>\n

Les mots d\u2019ordre : simplicit\u00e9 et efficacit\u00e9<\/strong>.<\/p>\n

Oui, il faut que tu r\u00e9diges la proc\u00e9dure avec des mots simples<\/strong>, faciles \u00e0 comprendre pour chaque collaborateur, qu\u2019il soit nouveau ou pas. Ces mots doivent d\u00e9crire au mieux l\u2019action \u00e0 r\u00e9aliser.<\/p>\n

Dans ces proc\u00e9dures, tu dois donner suffisamment de d\u00e9tails, mais pas trop non plus<\/strong>, pour pas qu\u2019elles deviennent complexes et d\u00e9courageantes pour le lecteur. Essaye de garder \u00e0 l\u2019esprit qu\u2019une proc\u00e9dure bien r\u00e9dig\u00e9e<\/strong> est une source de motivation<\/strong> pour celui qui va s\u2019en servir.<\/p>\n

Sur la forme, essaie d\u2019opter pour une mise en page a\u00e9r\u00e9e<\/strong>, agr\u00e9able \u00e0 lire. Tu peux \u00e9galement ajouter des sch\u00e9mas<\/strong>, des dessins<\/strong> qui vont beaucoup aider ceux qui ont une m\u00e9moire visuelle.<\/p>\n

Autre chose, tu peux t\u2019inspirer d\u2019autres proc\u00e9dures<\/strong> existant d\u00e9j\u00e0 au sein de l\u2019entreprise, pour rester conforme.<\/p>\n

Voici, par exemple, la structure d\u2019une proc\u00e9dure<\/span> :<\/em><\/p>\n

Nom de la proc\u00e9dure<\/strong> (Ex : \u00ab Proc\u00e9dure de visite de monitoring \u00bb)<\/p>\n

Cr\u00e9e par : (Nom de l\u2019employ\u00e9)<\/em><\/p>\n

Approuv\u00e9 par : (Nom d\u2019un autre employ\u00e9)<\/em><\/p>\n

1. Objet<\/span><\/strong> (ici, tu dois d\u00e9crire le but de la proc\u00e9dure, par exemple : \u00ab Cette proc\u00e9dure a pour but de d\u00e9crire la pr\u00e9paration, la r\u00e9alisation et le suivi d\u2019une visite de monitoring dans un centre \u00bb)<\/p>\n

2. Domaine d\u2019application<\/span><\/strong> (ici, tu vas d\u00e9tailler l\u2019ensemble des activit\u00e9s, des op\u00e9rations et\/ou des salari\u00e9s concern\u00e9s par la proc\u00e9dure et d\u00e9terminer les limites dans lesquelles cette proc\u00e9dure s\u2019applique, par exemple : Processus de monitoring au centre d\u2019investigation, ARC, chef de projet, stagiaire).<\/p>\n

3. Documents de r\u00e9f\u00e9rence<\/span><\/strong> (dans cette section, tu peux mettre les titres des documents de source externe et interne que tu utilises pour r\u00e9diger ta proc\u00e9dure. Par exemple \u00ab Code de la Sant\u00e9 Publique, Article R1123-39 \u00bb)<\/p>\n

4. Documents associ\u00e9s<\/span><\/strong> (ici, tu vas indiquer quels documents ou formulaires sont utilis\u00e9s, lors de la r\u00e9alisation de cette proc\u00e9dure. Par exemple \u00ab Rapport de visite de monitoring \u00bb)<\/p>\n

5. D\u00e9finitions<\/span><\/strong> (dans cette section, tu vas indiquer toutes les d\u00e9finitions des mots qui vont aider \u00e0 la compr\u00e9hension de la proc\u00e9dure, tu vas aussi d\u00e9crire les abr\u00e9viations que tu vas utiliser pour la r\u00e9daction. Par exemple \u00ab BPC<\/strong> = Bonnes Pratiques Cliniques \u00bb)<\/p>\n

6. Responsabilit\u00e9s<\/span><\/strong> (ici, tu d\u00e9finis qui est responsable d\u2019actions li\u00e9es \u00e0 cette proc\u00e9dure \u00ab Du c\u00f4t\u00e9 du promoteur : ARC, chef de projet \/ Du c\u00f4t\u00e9 du centre : M\u00e9decin investigateur, TEC, pharmacien \u2026)<\/p>\n

7. D\u00e9roulement<\/span><\/strong> (Enfin, dans cette section, tu vas entrer dans le vif du sujet, c\u2019est-\u00e0-dire que tu vas d\u00e9crire chacune des \u00e9tapes n\u00e9cessaires \u00e0 la r\u00e9alisation de l\u2019activit\u00e9. Par exemple : \u00ab -L\u2019ARC doit consulter le guide de monitoring avant toute action. L\u2019ARC prend contact avec l\u2019investigateur pour fixer une date de visite de monitoring. L\u2019ARC contacte \u00e9galement la pharmacie et les autres intervenants, si n\u00e9cessaire. \u00bb)<\/p>\n

Tout est dit. \u00c0 vos stylos \u2026 Pr\u00eat \u2026 R\u00e9digez !<\/p>\n

\n

Vous avez besoin d’une prestation en recherche clinique ? contactez PHARMASPECIFIC en vous rendant sur notre site en cliquant ici : https:\/\/pharmaspecific.com\/devis\/<\/a><\/strong><\/p>\n

Si tu as des questions sur le m\u00e9tier d\u2019attach\u00e9 de recherche clinique ou sur une carri\u00e8re dans la recherche clinique, tu peux la mettre dans les commentaires ci-dessous. Nous te r\u00e9pondrons dans les plus brefs d\u00e9lais.\u00a0<\/em><\/p>\n

Si tu veux \u00eatre coach\u00e9, si tu veux une r\u00e9ponse personnalis\u00e9e \u00e0 tes questions ou \u00eatre en contact avec d\u2019autres professionnels de la recherche clinique, tu peux te rendre sur\u00a0https:\/\/pharmaspecific-training.com\/<\/a><\/em><\/p>","protected":false},"excerpt":{"rendered":"

Article r\u00e9dig\u00e9 par la Soci\u00e9t\u00e9 Pharmaspecific, sp\u00e9cialiste en recherche clinique Bienvenue \u00e0 toi cher lecteur ! Aujourd\u2019hui, nous…<\/p>","protected":false},"author":4,"featured_media":3843,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":{"facebook_122143508198123560_331463380343150":""},"rop_publish_now_history":[],"rop_publish_now_status":"pending","_sitemap_exclude":false,"_sitemap_priority":"","_sitemap_frequency":"","_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[449],"tags":[16,41,259,290,24],"class_list":["post-3842","post","type-post","status-publish","format-standard","has-post-thumbnail","category-pratiquer-le-metier-dattache-de-recherche-clinique","tag-arc","tag-cro","tag-procedure-operatoire","tag-procedures-standardisees","tag-tec"],"translation":{"provider":"WPGlobus","version":"3.0.2","language":"en","enabled_languages":["fr","en"],"languages":{"fr":{"title":true,"content":true,"excerpt":false},"en":{"title":false,"content":false,"excerpt":false}}},"yoast_head":"\nComment \u00e9crire de SUPER proc\u00e9dures op\u00e9ratoires standardis\u00e9es? 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