Clinical Labels
Clinical labels* are one of the most important aspects of any clinical study.
Knowing at a minimum the answers to some of the following questions will help determine the correct label stock to be used:
| |
- What material are you labeling? (Plastic, Paper, Aluminum, etc)
- How is the material going to be stored and shipped? (Ambient, Refrigerated, Frozen, Etc.)
- Is the labeling being applied over a label? (is there a blinding issue)
- Does the label need to be opaque?
- Is moisture a concern?
|
Labels can be randomized, blinded, or open. Labels will sometimes include a variety of variable text information on each label. Label text can be provided by our clients or Siris can generate label text for your review and approval. We also offer multi-lingual labeling for your international needs. Label text for clinical labels should include at a minimum the following information:
|
|
- Study Number
- Name and Address of Sponsor
- Route of Administration
- Dose
- Caution Statements
- Storage Conditions
| |
Once label text is reviewed and meets all of the study requirements a proof will be generated. This proof will include at a minimum the following information for approval:
|
|
- Label Text
- Label Size
- Label ID
- Type of Stock (Material the label will be manufactured on)
- Color of the Stock
- Color of Ink
|
Once the proof is approved, the labels are ordered. The turnaround time for labels is approximately 10 business days from the date of order. Once labels are received at Siris they go through an extensive array of receiving and inspection procedures designed to assure the accuracy of each label received at Siris prior to release and use for a clinical trial.
|
*Siris approved vendor for labels is Citation Clinical Label Systems
|
|
