Drafting clinical trial agreement amendments is not the most exhilarating activity.
We negotiate and finalize clinical trial agreements with the hope that the written agreement will weather through the life cycle of the clinical study but at times, amendments are unavoidable. We may need to add, remove or change a clause or an exhibit in the agreement. Such modifications could arise from different reasons such as change in the study budget arising from a protocol amendment, changes in legislation or they could simply arise from human error.
In this post, I will show you how to draft clinical trial agreement amendments by walking you through some high-level, practical steps. I will also share some tips along the way to help you manage the process with ease. Read on and learn how to amend clinical trial agreements like a pro.
1. Locate the original clinical trial agreement.
This sounds like a no brainer, but you cannot amend an agreement if you simply do not know its original contents. Retrieve the original clinical trial agreement and read it. Check the clinical trial agreement for any clause directing how amendments are to be made and take the next step accordingly.
2. Identify the required modifications.
Pick-out the clauses you wish to modify in the original clinical trial agreement. Then, make a list of the modifications you wish to make to keep an overview. In so far possible, before drafting the clinical trial agreement amendment, share the intention to modify the clinical trial agreement upfront with the counter party/parties. This helps manage the expectations of the counter party/parties and prepare them for the amendments to come.
3. Start the drafting process.
a. Name your amendment. For example, you can call it an Agreement to Amend, Clinical Trial Agreement Amendment, Site Contracts Amendment or simply Amendment. As agreements may undergo multiple modifications or amendments, it is useful to number the clinical trial agreement amendment. You may also want to refer to the original clinical trial agreement and choose a name, style or format that is consistent with the original agreement.
b. Introduce the parties to the clinical trial agreement amendment. To this end, you may follow the format in the “heading” or “parties section” of the original clinical trial agreement.
c. Provide context to the amendment. You do this by identifying the clinical trial agreement that needs amendment and if you wish, provide some background to the events that led to the amendment process. Tell your “amendment story” in the “recital” or “background section” of the clinical trial agreement amendment.
d. Describe the amendments and state the effective date of the amendment. Note that the effective date of the amendment may also be stated in the “heading” or “parties section” of the clinical trial agreement amendment if that is your preference. Present the modifications or amendments concisely and precisely. Modifications or amendments are typically made using one of the three methods below:
i. Redlines and Strikethroughs
With this method, additions will be underlined and deletions will be struck out.
ii. Replacing a Clause in its Entirety
With this method, you state in the clinical trial agreement amendment that the clause is replaced entirely with the new one and produce the new clause.
iii. Describing the Changes
With this method, you simply describe the changes.
The table below illustrates the application of the 3 methods outlined above. For the purpose of illustration, let us assume that the clause requiring an amendment reads as follows and that the goal of the amendment is to change the term “Investigational Product” to “Study Drug.”
Section 12
On termination of this Agreement, the Institution must promptly return any unused Investigational Product to the Sponsor.
|
No. |
Method |
Illustration |
|
|
|
|
|
1. |
Redline and Strikethrough |
Section 12 is amended as follows: |
|
2. |
Replacing Clause in Entirety |
Section 12 is replaced in its entirety by the following: |
|
3. |
Describing the Changes |
Section 12 is amended by striking out the word “Investigational Product” and replacing it with “Study Drug.” |
You may choose to use any combination of the methods above if preferred. The key to considering the best combination is to take into account the nature or type of modification involved and balance it against the need to keep the amendment or modification presented in a direct, clear and simplistic fashion.
e. Confirm that the defined terms of the original clinical trial agreement apply unless otherwise expressly stated in the clinical trial agreement amendment.
f. Confirm that other than the amendments or modifications stated in the clinical trial agreement amendment, the other clauses in the original clinical trial agreement shall continue in full force.
g. Insert the signature blocks.
Voila! You now have a draft amendment to your clinical trial agreement. On to the next stage: you can now initiate the review process!
And, remember to file and maintain your agreement to amend with the main clinical trial agreement once it is finalized and signed. This ensures that anyone reviewing the clinical trial agreement in the future will be aware of the amendment made.
