Clinical trials registration and reporting

The request was successful.

Dear Sir/Madam,

Could you please provide the following information:

1. Does the university have a policy requiring those conducting clinical trials in humans to register those trials on a public clinical trials registry before the first participants are recruited? If yes, please provide a link to the policy.

2. Does the university have a policy requiring those conducting clinical trials in humans to post the results of those trials on a public clinical trials registry within 12 months of a trial being completed? If yes, please provide a link to the policy.

3. Does the university have a policy requiring those conducting clinical trials in humans to post the methodologies of those trials on a public clinical trials registry and/or different online platforms, and if so, within what time frame? If yes, please state the time frame and provide a link to the policy.

4. Does the university audit staff and contractor compliance with the policies referred to in questions 1-3? If yes, please provide a link to a document providing the most recent audit data, or if such data exist but are not online, please provide the relevant data.

5. How many clinical trials sponsored by the university were completed during the calendar year 2015?

6. How many clinical trials sponsored by the university that were completed during the calendar year 2015 have been registered on a public clinical trials registry as of today?

7. How many clinical trials sponsored by the university that were completed during the calendar year 2015 have posted results on a public clinical trials registry as of today?

8. Please provide the name of each clinical trial that was sponsored by the university and was completed during the calendar year 2015 that has not been registered on a public clinical trials registry as of today, together with the name and email address of the Principal Investigator (or equivalent position within the research team) of that trial.

9. Please provide the name and unique identification number of each clinical trial that was sponsored by the university and was completed during the calendar year 2015 that has not posted its results on a public clinical trials registry as of today, together with the name and email address of the Principal Investigator (or equivalent position within the research team) of that trial.

Thank you for your time, I look forward to hearing from you,

Till Bruckner

FOI, University of Cambridge

This is to acknowledge receipt of your request for information. Your reference number is given in the subject line of this email. We will respond on or before 27 March 2017.

Regards,

Freedom of Information Office
University of Cambridge
Registrary's Office, The Old Schools
Trinity Lane, Cambridge, CB2 1TN
T: (01223 7)64142
F: (01223 3)32332
E: [email address]

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FOI, University of Cambridge

1 Attachment

Further to your request for information, please find attached the University’s response.

Regards,

Freedom of Information Office
University of Cambridge
Registrary's Office, The Old Schools
Trinity Lane, Cambridge, CB2 1TN
T: (01223 7)64142
F: (01223 3)32332
E: [email address]

show quoted sections

Dear FOI,

thank you very much for the information. Keep an eye on www.TranspariMED.org for an upcoming blog based on your response.

Yours sincerely,

Till Bruckner

Dear FOI,

I just reviewed your response and discovered that it does not cover Qs 1-4. Could you please individually answer Qs 1, 2, 3, and 4?
If applicable, you could simply answer "No" to each question.

Your answers to Qs 5-9 are satisfactory, thank you.

Please let me know whether I can expect an answer to Qs 1-4 in response to this message, and by what date, or whether I should instead formally request an internal review of your decision.

RSVP.

Yours sincerely,

Till Bruckner

FOI, University of Cambridge

Dear Till Bruckner,

Thank you for your email. For the reasons given in our original response letter (i.e. that any such policies in relation to clinical trials are not University policies), the factual answers to your Q1-4 are as follows:

Q1. No
Q2. No
Q3. No
Q4. No

Regards,

Freedom of Information Office
University of Cambridge
Registrary’s Office, The Old Schools
Trinity Lane, Cambridge, CB2 1TN
T: (01223 7)64142
F: (01223 3)32332
E: [email address]

show quoted sections

Dear FOI,

thank you very much for the information.

Yours sincerely,

Till Bruckner

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