KudoZ home » English to French » Medical (general)

Final Investigational Product Reconciliation Statement

French translation: déclaration de fin de bilan comparatif du produit expérimental

Advertisement

Login or register (free and only takes a few minutes) to participate in this question.

You will also have access to many other tools and opportunities designed for those who have language-related jobs
(or are passionate about them). Participation is free and the site has a strict confidentiality policy.
GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:Final Investigational Product Reconciliation Statement
French translation:déclaration de fin de bilan comparatif du produit expérimental
Entered by: Drmanu49
Options:
- Contribute to this entry
- Include in personal glossary

13:12 Mar 11, 2007
English to French translations [PRO]
Medical (general)
English term or phrase: Final Investigational Product Reconciliation Statement
"At study initiation and as needed thereafter, XXX and placebo will be shipped to a responsible person (eg, a pharmacist) at the investigator’s institution, who will check the amount and condition of the drug and enter these data into the Proof of Receipt Form and Investigational Product Accountability Record. (...) All used and unused vials of XXX or placebo must be retained for monitor verification or the site may follow the institutional standard operating procedure for vial disposal. If the site SOP is elected as the disposal procedure, the SOP must be provided to the Sponsor.

An Investigational Product Accountability Record for XXX and placebo mandated by the protocol must be kept current and should contain:
• the dates and quantities of investigational product received from Amgen
• packaging lot numbers for product received
• subject’s identification
• date and quantity of investigational product dispensed
• the initials of the dispenser
• dose preparation records

The Return of Investigational Product for Destruction Form must be completed and included in the shipment of used and unused investigational product to Amgen. At the end of the study, the Final Investigational Product Reconciliation Statement must be completed and provided to Amgen.

These inventories must be made available for inspection by an authorized Amgen representative and regulatory agency inspectors. The investigator is responsible for the accountability of all used and unused clinical study supplies."


Par ailleurs, concernant les divers formulaires dont il est question dans ce passage :

-"Return of Investigational Product for Destruction Form" = "retour du produit expérimental en vue de sa destruction" ?

- "Proof of Receipt Form" = formulaire d'accusé réception ?

- "Investigational Product Accountability Record" = registre de comptabilité du produit expérimental ?
Celine Rosselot
Local time: 10:17
déclaration de fin de bilan comparatif du produit expérimental
Explanation:
-"Return of Investigational Product for Destruction Form" = "retour du produit expérimental en vue de sa destruction" ?

- "Proof of Receipt Form" = formulaire d'accusé réception

- "Investigational Product Accountability Record" = registre de comptabilité du produit expérimental??
Selected response from:

Drmanu49
France
Local time: 10:17
Grading comment
Merci Drmanu.
4 KudoZ points were awarded for this answer

Advertisement


Summary of answers provided
4 +3déclaration de fin de bilan comparatif du produit expérimental
Drmanu49


  

Answers


16 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
final investigational product reconciliation statement
déclaration de fin de bilan comparatif du produit expérimental


Explanation:
-"Return of Investigational Product for Destruction Form" = "retour du produit expérimental en vue de sa destruction" ?

- "Proof of Receipt Form" = formulaire d'accusé réception

- "Investigational Product Accountability Record" = registre de comptabilité du produit expérimental??

Drmanu49
France
Local time: 10:17
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 4700
Grading comment
Merci Drmanu.
Notes to answerer
Asker: Merci Drmanu ;-)


Peer comments on this answer (and responses from the answerer)
agree  Assimina Vavoula
18 mins
  -> Thank you Assimina.

agree  cjohnstone
56 mins
  -> Thank you Catherine.

agree  DR CHATONNETNÉ Pálma, MS, MA Translation
2 hrs
  -> Thank you Palma.
Login to enter a peer comment (or grade)




Return to KudoZ list


KudoZ™ translation help
The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.



See also:



Term search
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search