Manufacturing
Holding a sample somebody entrusted to you
Something was entrusted to you for a specific use and a specific time. The hard part is not storing it: it is showing what was done with it.
You receive material from a third party —a customer, a hospital, an institute, another company— to do something specific with it. **It came with conditions**: what it may be used for, for how long, what happens to what remains and what may be published or communicated about the results. Those conditions were agreed once, at the start, and from then on the real work is demonstrating they were respected.
What must be demonstrable, and it is not what it seems
| What is asked | What is usually held | What is needed |
|---|---|---|
| Did you receive it? | The signed agreement | It is usually there |
| What was it used for? | The project's results | **The use, not only the result** |
| Who handled it? | In the team's heads | A record per person |
| **What remains and where?** | **An estimate** | **The actual inventory** |
| **And the surplus?** | **It depends** | **What was agreed, done and recorded** |
Important
**The agreement is signed once and compliance must be demonstrable for years, including the parts performed at the very end.** That is the asymmetry in this position: an initial document generates continuing obligations —of use, of custody, of final disposition— that nobody rereads and that are only checked once the project has ended, the team has dispersed and what happened has to be reconstructed.
What to record from receipt onwards
- 1
What was received, how much and under what conditions
With the agreement's terms linked, not in another drawer.
- 2
Each use: who, when, how much and what for
It is the record that almost never exists and always gets asked for.
- 3
Where whatever remains is
By actual inventory, not by what should remain on paper.
- 4
And what was done at the end
Return or final disposition, evidenced and dated.
Watch out
The most fragile moment in the whole cycle is **the end of the project**, precisely because by then nobody is interested: the results are in, the team has moved on, and what remains of the material is a tube in a freezer. Obligations about final disposition are almost always breached there, with no decision taken at all — and it is the part of the agreement most often checked afterwards, because it is the only one with a date attached.
Worth knowing
What may be agreed in a material transfer agreement, what custody, use and disposition obligations it creates, and what regime applies to associated data or to material of human origin **depends on the material and the applicable rules, and is settled by your adviser**. Here we cover the organisational part: how to record receipt, uses and disposition to demonstrate compliance years later.
›Is keeping the signed agreement enough?
It is the start. What gets checked is what was done afterwards.
›Must every use be recorded?
It is the record most often asked for and least often held.
›What happens when the project ends?
Whatever the agreement says, and it must be demonstrable that it was done.
A real case
The situation
Questions arrive about what was done with material transferred three years ago.
What you do
- Keeps the record of uses alongside the agreement
What you get
It is answered from the history, not from memory.
The situation
The agreement sits in a drawer and its terms are not remembered.
What you do
- Links the terms to the material's file
What you get
The obligations live where the work happens.
The situation
Nobody knows how much of a sample actually remains.
What you do
- Records each consumption at the moment
What you get
The inventory is real rather than calculated.
The situation
The project ends and the final disposition is not on record.
What you do
- Warns about obligations with an attached date
What you get
Closing the agreement is performed and documented.
The situation
It is unclear who handled the material at each point.
What you do
- Stores author and date on every entry
What you get
The chain of custody can be reconstructed.
The situation
The team disperses and the knowledge goes with it.
What you do
- Keeps the file accessible independently of individuals
What you get
The project stays explicable afterwards.
This article answers
- material transferred for a project what to document
- material transfer agreement
- traceability of received samples
- what happens to the sample when the project ends