UCL Institute of Clinical Trials and Methodology



The ICTM Contracts Team are responsible for drafting and negotiating all the Institute’s research contracts and are here to provide you with advice and support on all contractual matters.

  • All members of staff should read and familiarise themselves with the ICTM Contracts SOP, which can be provided on request to the ICTM Contracts Team
  • Further information on all aspects of the ICTM Contracts process can also be found on the Contract Information Form, the latest version of which can also be provided on request to the ICTM Contracts Team
  • It is also helpful to familiarise yourself with the Contracts Administration Process flowchart.

Frequently asked questions

The following FAQs should help you to understand and plan your contracting needs and expectations more effectively:

Question 1. How are contract amendments handled?

Amendments are always dependent on the contract in question.

If you are amending a research contract, then the ICTM Contracts Team should be contacted for advice. Where an amendment is minor, such as amending the term of the Agreement, the ICTM Contracts Team might simply provide you with an Amendment Template so you can arrange this yourself and send it to the external party. However, in the first instance please do consult with us. 

If there is a need to amend a mNCA please still contact the ICTM Contracts Team to ensure the change is in-keeping with the nationally agreed terms for the template.

Question 2. When can we use a non-UCL template?

In most cases it is preferable we use an ICTM-issued template.

If the external party insists on using their own template then the ICTM Contracts Team should be provided with the template in order to comment on it and adjust as needed to ensure it meets all required UCL terms for contracting. 

UCL are sometimes able to use a third party’s own template, for example the generic Quality Assurance Template for the IMP service. However, even in the case of a ‘generic’ template such as this, UCL are not able to accept any further party-specific terms and conditions embedded in its appendices in addition to the generic content in the main body of the contract. 

Question 3. What’s the difference between start / end date and effective date?

The start and end dates are the dates of the start / end of the project or the funding. The effective date is the date the contract comes into effect, along with all liabilities and responsibilities included in the contract. This is one of the reasons why it is important that contracts are concluded and in effect before any work starts so that the project and UCL are fully protected. The effective date is never made prior to the date the final signature has been made on the contract.

Question 4. Are we able to discuss the contract terms with the external party?

To enable the ICTM Contracts Team to negotiate on a fair and equal footing, we request that contractual terms are not discussed with external parties. 

Expectations of ‘perceived’ agreed terms causes upset to both parties. Disappointment upon realisation that such terms cannot be accepted inevitably leads to protracted negotiations and otherwise avoidable delays. 

Question 5. Why are there a lack of templates available to use?

The contracts drafted by the ICTM Contracts Team are bespoke and unique in their nature: no two contracts will ever be quite the same and require no changes or negotiation of terms. 

Question 6. When does the ICTM Contracts Team engage with us?

The ICTM Contracts Team will engage with you following receipt of a Contract Information Form (CIF) right through to the signature process. 

Following the receipt of the CIF a member of the ICTM Contracts Team will contact you to discuss your needs in further detail and you will be notified of the team member who will lead on the draft of your contract (the lead may change where one of the team is absent or there are extenuating circumstances that require a change in lead). 

If necessary we will advise on meeting to discuss contractual needs further to our review of the CIF. However, if your needs are  straightforward (for example arranging a  Data Sharing Agreement) a discussion may not be necessary. So do not be alarmed if you do not receive an invitation to meet.  

Question 7. When does the ICTM Contracts Team engage with other colleagues?

The ICTM Contracts Team may engage with other colleagues in UCL before or during the contract draft stage right through to completion of the contract.  The following  is an example of a contract that requires involvement from a number of UCL colleagues: 

Scenario: Contract includes an IT service, EU funding, personal data processing, sub-contractors, industry partners and complex IP rights.

UCL Services involved or consulted:

  • Procurement - for the appointment of a supplier
  • European Office - for the EU funding terms
  • Translational Research Office (TRO) - for industrial partner collaboration
  • UCL Business (UCLB) - for IP rights assignment with industrial partners
  • RSD - for any pre-approved templates, budget breakdown and eventual sign-off
  • Insurance - for any specific insurance / indemnity issues
  • Data Protection and Freedom of Information Office - for the processing and control of personal data
Question 8. When does the ICTM Contracts Team engage with an external party?

The ICTM Contracts Team will engage with an external party immediately to initiate the contract drafting process. The earlier this occurs, the smoother and less pressured the contract process will be. 

We strive to engage with external parties as soon as appropriate to minimise anxiety caused by time pressures and possible delays to projects starting on time.

Question 9. The external party has contacted me directly requesting a change to UCL’s standard terms and conditions, can I agree to the change?

UCL is a public organisation with charity status and as such is unable to agree to certain terms. Any requests you may receive from an external party to change UCL’s terms should be sent to the ICTM Contracts Team for consideration.  We will then respond directly to the external party.  You should refrain from indicating that a change is, or might be, acceptable as this leaves the ICTM contract lead in a difficult and compromised position when we come to explain why it might not be possible to agree to a change in UCL’s contractual terms.

Question 10. How can I help the contract process?

Your assistance is vital to the entire contracting process. 

In particular, the information we receive from you in the CIF; your expertise on data issues; on publication terms; on IP rights; and on all technical aspects of the project will be the foundation on which the final contract will ultimately stand. Past experiences have shown the following are also key triggers for a quicker contracts process:

  • having only one identified individual to channel communication to and from the ICTM Contracts Team, thus removing duplication of emails; 
  • CPMs and Trial Managers facilitating the communication process by ensuring that emails received are cascaded down through their teams as appropriate; 
  • providing your collaborating partners with ICTM Contracts Team’s contact details early on to enable contractual discussions to begin as soon as appropriate;  
  • refraining from using old templates or agreeing to use the external party’s own template that may contain unsuitable terms and clauses;
  • contacting the ICTM Contracts Team as early as possible about your contracting needs; and
  • contacting the ICTM Contracts Team for advice and assistance for any specialist activities, for example procuring a service, supplier or goods.
Question 11. What may cause a delay to having a final contract version?

Delays may be due to a number of reasons, the most common include:

  • The ICTM Contracts Team not having the correct details of the external party’s legal rep/contract manager or institution;
  • Complexities in the agreement which require in-depth discussion and negotiation;
  • Awaiting clarification / feedback from the other party or parties on contractual terms (or confirmation of agreement to them);
  • Awaiting contractual documents not in-hand: i.e., insurance certificate; project details; scope of works; roles and responsibilities; payments or budget information;
  • Waiting for approvals;
  • External party not being in a position to commit to a contract;
  • Temporary absence of a party who is key to the process; and
  • Other external factors (i.e., change in focus, illness) beyond the control of either party.
Question 12. How does RSD feature in the process?

UCL's Research Services Division is the department that has responsibility for all research-related contracts and is currently the sole signatory point for those research contracts where there is a financial element involved and/or UCL is the legal entity.

RSD also maintain, manage, process and account on all financial details of a research contract on behalf of UCL. RSD may be contacted by the ICTM Contracts Team for a number of reasons, including: clarification of UCL-acceptable terms; previous dealings or contract precedents with a known supplier; template updates; corporate and company law queries; novations; credit checks; funding streams; letters of support; legal precedents, etc.

Question 13. Is it possible to initiate a quicker contract process cycle?

Due to its bespoke nature (and the unpredictable nature of negotiating with external parties), it is difficult to guarantee ‘efficiencies’ or precise timeframes for any given contract. Some contracts are very quick to place; others take longer.

Past experience shows that the sooner colleagues communicate to the ICTM Contracts Team the possible need for a contract, the sooner steps can be taken to initiate and carry through the contract process. Where efficiencies can be identified by ICTM Contracts they will, of course, be implemented to the best of our abilities.

Question 14. Do we always have to have some sort of agreement in place?

The short answer is: yes. 

A contract sets out the rights, duties and obligations of each party and it also clarifies the manner in which the parties shall operate in relation to these rights and obligations.  The contract also details the law the parties shall submit to and that will govern any dispute, should a dispute arise. It may also outline other mechanisms for resolving disputes or providing protection for the parties. Further, a contract clearly states all requirements for compliance with recognised practices or procedures as appropriate to the specific obligations and context of that contract. In light of this, there are unacceptable risks to UCL to carry out any part of a project without an appropriate agreement in place. 

Question 15. Why can we not use a template for a new contract that is largely similar in nature to an existing one?

Each contract will be unique in its criteria, the parties involved, the specific nature of the study, etc. Therefore, what may have been agreed and accepted for a previous contract will not be transferable to the next. 

It is not good practice to use a previous template as there may be unsuitable terms, inappropriate indemnities, conflicting clauses or other aspects that may delay contract drafting. It is best that a contract is started from scratch by the ICTM Contracts Team: the time taken to deconstruct or ‘make fit’ a previous contract template is normally greater than beginning the contract from fresh. 

Question 16. There is pressure to put a contract in place quickly on short notice, will the ICTM Contracts Team be able to do this?

Contracts are drafted in a timely manner wherever possible.   

It is important to note, however, that all due diligence must be undertaken internally as well as externally before a contract can be completed. In view of the multi-faceted contracts process, it may not always be possible for the ICTM Contracts Team to meet a strict deadline, though we will always endeavour to do what we can to assist in meeting deadlines.

Question 17. Will I be copied on to all correspondence surrounding the contract?

Yes, in the majority of cases. 

There may be the rare occasion when this is not possible. However, the ICTM Contracts Team will of course keep you informed and updated on the progress of a contract at all stages of its progression through the contracts process.