Service Provider Sector - Projects for 2015

Pharmaceutical Language Services

This sector provides specialist translation and quality assurance services of clinical trial documents to pharmaceutical companies and Contract Research Organisations (CROs).

The aim of the projects planned for 2015-2016 is to improve the quality and effectiveness of both English and translated patient-facing documents, such as ICFs, Diaries, Questionnaires, etc. in order to ultimately improve participant compliance and retention.

The main projects for 2015-2016 are:

  • ICFs-made-easy workshops:

  • ICF localisation;

  • the use of plain language to improve readability;

  • tips, tricks and shortcuts for easy formatting and consistency; and

  • dealing with translation agencies.

  • Creating resources to aid CRAs in working with ICFs:

  • standardised terminology checklists for each ethics committee;

  • plain language checklists;

  • lists of plain language alternatives for difficult terminology; and

  • multilingual terminology lists.

  • Regular mailshots on:

  • effective communication;

  • language and grammar tips;

  • ICF tips; and

  • news from the language industry.

Project 2:

Biological Sample transfer and Permits

1. Signature on application form

NDOH are still get application forms that are not signed (the word format). If applicants are sending word format they must also send PDF with signature of the applicant.

2. Substance and Quantity

Applications stating "Human Substance under Substance on the application form. Applicants must be specific: E.g. Blood, Urine, etc.

The quantity must not just say 50 Samples, they must be specific, and we need quantity in volume, e.g. 10 ml of blood, mass: 1 gram of liver, Plus the number of samples and number of visits. E.g. 10ml x 10 samples/tubes/vials/bottles x 10 visits

3. Protocol/study/Ethics Number

This must reflect on the application form and not just the covering letter or subject of the E-mail. Applicants must check the outcome of the application within a reasonable time frame, not after two months, It is time consuming to go through the archives, NDOH staff have to physically go through papers, do not have electronic archiving system yet.

Project 3:

Customs Vat – importing Investigational products